TOTAL 510(k)s THIS PERIOD   257                                     TOTAL WITH SUMMARIES        240                                     TOTAL WITH STATEMENTS        17

DEVICE: ACCESS TOTAL BHCG (5TH IS) BECKMAN COULTER, INC.             510(k) NO: K130020(TRADITIONAL) ATTN: GERALDINE L BAGLIEN         PHONE NO : 952 368 7645   1000 LAKE HAZELTINE DR.           SE DECISION MADE: 01-OCT-13 CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K131975(TRADITIONAL) ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   4 HENDERSON DRIVE                 SE DECISION MADE: 02-OCT-13 WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) ALFA SCIENTIFIC DESIGNS, INC.     510(k) NO: K131645(ABBREVIATED) ATTN: NAISHU  WANG                PHONE NO : 858 513 3888   13200 GREGG ST.                   SE DECISION MADE: 07-OCT-13 POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDAS C DIFFICILE GDH BIOMERIEUX SA                     510(k) NO: K132010(TRADITIONAL) ATTN: CAROLINE  KOCH-MATHIAN      PHONE NO : 33 478877 032 5 RUE DES AQUEDUCS                SE DECISION MADE: 09-OCT-13 CRAPONNE    FR 69290              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST-ST TIGECYCLINE BIOMERIEUX, INC.                  510(k) NO: K131779(TRADITIONAL) ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666   595 ANGLUM RD.                    SE DECISION MADE: 10-OCT-13 HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS OPERATIONS INC  510(k) NO: K131366(TRADITIONAL) ATTN: NATHAN  CARRINGTON          PHONE NO : 317 521 4793   9115 Hague Rd                     SE DECISION MADE: 11-OCT-13 Indianapolis IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMDX C.DIFFICILE FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC. 510(k) NO: K132235(TRADITIONAL) ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   180 CABOT ST                      SE DECISION MADE: 11-OCT-13 BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K132664(TRADITIONAL) ATTN: KIRA  GORDON                PHONE NO : 914 524 2996   511 BENEDICT AVE                  SE DECISION MADE: 16-OCT-13 TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM NOVA BIOMEDICAL CORPORATION       510(k) NO: K131013(TRADITIONAL) ATTN: PAUL W MACDONALD, PHD       PHONE NO : 781 894 0800   200 Prospect St                   SE DECISION MADE: 17-OCT-13 WALTHAM MA 02454                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRSA/SA ELITE MGB, ELITE MGB SOFTWARE ELITECHGROUP EPOCH BIOSCIENCES    510(k) NO: K132468(TRADITIONAL) ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5555   21720 23rd Dr SE, Suite 150       SE DECISION MADE: 17-OCT-13 Bothell WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) HOLOGIC / GEN-PROBE INCORPORATED  510(k) NO: K132251(TRADITIONAL) ATTN:                             PHONE NO : 10210 GENETIC CENTER DRIVE        SE DECISION MADE: 17-OCT-13 SAN DIEGO CA 92121 4376           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE LUMIQUICK DIAGNOSTICS, INC.       510(k) NO: K130213(TRADITIONAL) ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046   27001 LA PAZ RD, STE 266B         SE DECISION MADE: 18-OCT-13 MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR BIOPHOR DIAGNOSTICS, INC.         510(k) NO: K132096(TRADITIONAL) ATTN: NATHANIEL G BUTLIN          PHONE NO : 650 367 4954   1201 DOUGLAS AVE                  SE DECISION MADE: 18-OCT-13 REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPLEX 2200 APLS IGM BIO-RAD LABORATORIES              510(k) NO: K130528(TRADITIONAL) ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   5500 E. 2ND STREET                SE DECISION MADE: 21-OCT-13 BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC.           510(k) NO: K123713(TRADITIONAL) ATTN: KEVIN J LAWSON              PHONE NO : 716 691 0091   60 PINEVIEW DR.                   SE DECISION MADE: 25-OCT-13 BUFFALO NY 14228 2120             510(k) STATEMENT

DEVICE: S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K132462(TRADITIONAL) ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   575 SHIRLYNN COURT                SE DECISION MADE: 28-OCT-13 LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K123711(TRADITIONAL) ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   12226 WASHINGTON LANE             SE DECISION MADE: 01-OCT-13 PARKER AZ 85344                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MPACT DM LINER CONVERTER MEDACTA INTERNATIONAL             510(k) NO: K131458(TRADITIONAL) ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 01-OCT-13 CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY MICROLIFT FACIAL TONING DEVICE CAROL COLE COMPANY                510(k) NO: K131251(TRADITIONAL) ATTN: RAND  DAOUD                 PHONE NO : 760 734 4545   1325 Sycamore Ave Ste A           SE DECISION MADE: 01-OCT-13 Vista CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION              510(k) NO: K132600(SPECIAL) ATTN: ELIZABETH  WHEELER          PHONE NO : 904 741 4400   1520 TRADEPORT DR.                SE DECISION MADE: 02-OCT-13 JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY     510(k) NO: K132693(SPECIAL) ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 02-OCT-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K130947(TRADITIONAL) ATTN: LEI  CHEN                   PHONE NO : 86 10 88798300 No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 03-OCT-13 BEIJING    CN 100041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE SILICONE FOLEY CATHETER GUANGDONG BAIHE MEDICAL TECHNOLOGY510(k) NO: K130908(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 PO BOX 120-119                    SE DECISION MADE: 03-OCT-13 SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEANSER ROOT CANAL CERKAMED WOJCIECH PAWLOWSKI       510(k) NO: K130180(TRADITIONAL) ATTN: KINGA  WIERUCKA             PHONE NO : 481 584235 85 KWIATKOWSKIEGO 1 STREET           SE DECISION MADE: 03-OCT-13 STALOWA WOLA, PODKARPACIE    PL 37510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEDEX DENTMATE TECHNOLOGY CO., LTD.     510(k) NO: K131042(TRADITIONAL) ATTN: CHENG-FENG  CHOU            PHONE NO : 866 289769 226 8F, No.8-11, Sec.1, Zhongxing RoadSE DECISION MADE: 03-OCT-13 New Taipei City    TW 24872       510(k) STATEMENT

DEVICE: EVEREST SPINAL SYSTEM K2M, INC.                         510(k) NO: K132361(TRADITIONAL) ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   751 MILLER DR.,SE                 SE DECISION MADE: 03-OCT-13 LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOTEX POWDER-FREE NITRILE SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K122557(TRADITIONAL) ATTN: JEN  KE-MIN                 PHONE NO : 862 159 799888 NO. 369, JIASONG ZHONG ROAD HUAXINSE DECISION MADE: 03-OCT-13 SHANGHAI    CH 201708             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCCLUSION PERFUSION CATHETER ADVANCED CATHETER THERAPIES, INC. 510(k) NO: K130525(TRADITIONAL) ATTN: CHRIS  HENZA                PHONE NO : 262 842 1257   7401 104TH AVE                    SE DECISION MADE: 03-OCT-13 KENOSHA WI 53142                  510(k) STATEMENT

DEVICE: NEO KNEE SYSTEM PIPELINE ORTHOPEDICS              510(k) NO: K131368(TRADITIONAL) ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   901 KING STREET, SUITE 200        SE DECISION MADE: 03-OCT-13 ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMCAD-UT DETECTION MODEL 2.0 LIN & ASSOCIATES, LLC.            510(k) NO: K122536(TRADITIONAL) ATTN: CHIU S LIN                  PHONE NO : 301 591 3895   9223 CAMBRIDGE MANOR COURT        SE DECISION MADE: 03-OCT-13 POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DICOM VIDEO BAR CODE COMPUTER LTD             510(k) NO: K132183(TRADITIONAL) ATTN: DAN  LAOR                   PHONE NO : 972 4 8246632 6 SIRENI                          SE DECISION MADE: 03-OCT-13 HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, ETHICON ENDO-SURGERY, LLC         510(k) NO: K131435(TRADITIONAL) ATTN: MARICA  ARENTZ              PHONE NO : 513 337 1066   4545 CREEK ROAD                   SE DECISION MADE: 03-OCT-13 CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANYSCAN-S SPECT IMAGING SYSTEM ABSOLUTE IMAGING SOLUTIONS        510(k) NO: K131625(TRADITIONAL) ATTN: MARK  SHINA                 PHONE NO : 336 643 2000   8205 B&G COURT                    SE DECISION MADE: 03-OCT-13 STOKESDALE NC 27357               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATUS WARMETTE BLANKET AND DUAL CABINETS NATUS NICOLET IRELAND LTD         510(k) NO: K132110(TRADITIONAL) ATTN: MICHAEL  GALVIN             PHONE NO : 353 091 647451 IDA BUSINESS PARK                 SE DECISION MADE: 03-OCT-13 GORT, COUNTY GALWAY    EI IE      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVAFLEX VERTEBRAL BALLOON SYSTEM CAREFUSION                        510(k) NO: K131824(TRADITIONAL) ATTN: JOY  GREIDANUS              PHONE NO : 847 473 7404   75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 03-OCT-13 VERNON HILLS IL 60061             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K132774(SPECIAL) ATTN: YAEL  RUBIN                 PHONE NO : 972 9 9511511 11 HA’HOSHLIM STREET              SE DECISION MADE: 03-OCT-13 HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTIFIL BULK FLOWABLE SHOFU DENTAL CORPORATION          510(k) NO: K132141(TRADITIONAL) ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   1225 STONE DRIVE                  SE DECISION MADE: 03-OCT-13 SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST DEROYAL INDUSTRIES, INC.          510(k) NO: K132199(TRADITIONAL) ATTN: COURTNEY  RINEHART          PHONE NO : 865 362 2122   200 DEBUSK LN.                    SE DECISION MADE: 03-OCT-13 POWELL TN 37849                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 AAP IMPLANTATE AG                 510(k) NO: K132554(TRADITIONAL) ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 004 930 75019193 LORENZWEG 5                       SE DECISION MADE: 03-OCT-13 BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED FLOWGATE BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC.          510(k) NO: K131492(TRADITIONAL) ATTN: RHODA  SANTOS               PHONE NO : 510 413 2269   301 E Evelyn Ave                  SE DECISION MADE: 03-OCT-13 MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL            510(k) NO: K132575(SPECIAL) ATTN: AUDREY  VION                PHONE NO : 33 47 2018787 14 Porte du Grand Lyon            SE DECISION MADE: 03-OCT-13 NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC.        510(k) NO: K132675(SPECIAL) ATTN: NICOLE  BARBER              PHONE NO : 210 497 6682   18615 Tuscany Stone Ste 100       SE DECISION MADE: 03-OCT-13 San Antonio TX 78258              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAUTILUS SPINAL SYSTEM LIFE SPINE, INC                   510(k) NO: K132760(SPECIAL) ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 03-OCT-13 HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K131673(TRADITIONAL) ATTN: KELLY  ANGLIN               PHONE NO : 901 396 3133   1800 PYRAMID PLACE                SE DECISION MADE: 03-OCT-13 Memphis TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMOCHEM HT-2000 THERMASOLUTIONS, INC.             510(k) NO: K131583(TRADITIONAL) ATTN: M.W. ANDY  ANDERSON PH.D. RAPHONE NO : 952 746 8079   5353 WAYZATA BOULEVARD SUITE 505  SE DECISION MADE: 03-OCT-13 MINNEAPOLIS MN 55416              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLONGLIDE(R) LUBRICANT PEDIATRIC PHARMACEUTICALS, INC.   510(k) NO: K131617(TRADITIONAL) ATTN: ROBERT M HARRIS             PHONE NO : 732 739 2018   2137 ROUTE 35                     SE DECISION MADE: 03-OCT-13 HOLMDEL NJ 07733                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCKING PLATE SYSTEM BEIJING LIBEIER BIO-ENGINEERING IN510(k) NO: K132642(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 03-OCT-13 SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G CAREFUSION                        510(k) NO: K131820(TRADITIONAL) ATTN: JOY  GREIDANUS              PHONE NO : 847 473 7404   75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 04-OCT-13 VERNON HILLS IL 60061             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISCHEMA VIEW RAPID ISCHEMA VIEW, INC.                510(k) NO: K121447(TRADITIONAL) ATTN: MARC  GOODMAN               PHONE NO : 949 548 3980   5405 ALTON PARKWAY 5A, #530       SE DECISION MADE: 04-OCT-13 IRVINE CA 92604                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNER PEACE KAMABRY, INC., DBA INNER PEACE FOR510(k) NO: K122800(TRADITIONAL) ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   1468 HARWELL HAVE                 SE DECISION MADE: 04-OCT-13 CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFAST CK-MB-II CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPO510(k) NO: K130628(SPECIAL) ATTN: JUDI  SMITH                 PHONE NO : 240 316 3377   2 BETHESDA METRO CENTER SUITE 850 SE DECISION MADE: 04-OCT-13 BETHESDA MD 20814                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD          510(k) NO: K132861(TRADITIONAL) ATTN: KYEONG-MI  PARK             PHONE NO : 82 2 21941373 42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 04-OCT-13 SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES MEDTRONIC, INC.                   510(k) NO: K132645(TRADITIONAL) ATTN: CHELSEA  PIOSKE             PHONE NO : 763 514 9838   7611 NORTHLAND DRIVE              SE DECISION MADE: 04-OCT-13 MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC.            510(k) NO: K132440(SPECIAL) ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066   3600 HOLLY LANE NORTH SUITE 40    SE DECISION MADE: 04-OCT-13 PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX IBL SYSTEM SPINE WAVE, INC.                  510(k) NO: K132719(SPECIAL) ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   3 ENTERPRISE DR. SUITE 210        SE DECISION MADE: 04-OCT-13 SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED         510(k) NO: K132768(SPECIAL) ATTN: TOKI  WU                    PHONE NO : 86 755 26722890 YIZHE BLDG, YUQUAN ROAD           SE DECISION MADE: 04-OCT-13 SHENZHEN, GUANGDONG    CH 518051 P510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER ARTERIOCYTE MEDICAL SYSTEMS, INC. 510(k) NO: K132905(TRADITIONAL) ATTN: ANN  CHAREST                PHONE NO : 508 497 8964   45 SOUTH STREET                   SE DECISION MADE: 04-OCT-13 HOPKINTON MA 01748                510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: MICROPLEX COIL SYSTEM (MCS) MICROVENTION, INC.                510(k) NO: K131948(SPECIAL) ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   1311 VALENCIA AVE                 SE DECISION MADE: 04-OCT-13 TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT ARTHROCARE CORP.                  510(k) NO: K131709(SPECIAL) ATTN: ASHLEY  DAWSON              PHONE NO : 512 358 5773   7000 W.WILLIAM CANNON DRIVE BUILDISE DECISION MADE: 04-OCT-13 AUSTIN TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAHEAT PATIENT WARMING SYSTEM VITAHEAT MEDICAL, LLC             510(k) NO: K132454(TRADITIONAL) ATTN: JACK  SLOVICK               PHONE NO : 763 639 0238   1585 BEVERLY DR. #121             SE DECISION MADE: 04-OCT-13 AURORA IL 60502                   510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: SMARTSITE VIALSHIELD YUKON MEDICAL, LLC                510(k) NO: K132863(TRADITIONAL) ATTN:                             PHONE NO : 2200 Gateway Centre Blvd Ste 208  SE DECISION MADE: 04-OCT-13 Morrisville NC 27560              510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: KYMCO EQ20C SCOOTER KWANG YANG MOTOR CO., LTD.        510(k) NO: K130940(TRADITIONAL) ATTN: JUNNATA  CHANG              PHONE NO : 886 4 22465396 16F-2 (16A), NO. 462, SEC. 2, CHONSE DECISION MADE: 07-OCT-13 BEITUN DIST., TAICHUNG    TW 406  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET COOK, INC.                        510(k) NO: K131201(TRADITIONAL) ATTN: ERUM B NASIR                PHONE NO : 812 339 2235   750 DANIELS WAY                   SE DECISION MADE: 07-OCT-13 Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISI MOBILE MONITORING SYSTEM SOTERA WIRELESS, INC              510(k) NO: K130709(TRADITIONAL) ATTN: EBEN  GORDON                PHONE NO : 858 373 4841   9444 WAPLES STREET                SE DECISION MADE: 07-OCT-13 SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRELLIS COLLAGEN RIBBON WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K131143(TRADITIONAL) ATTN: SARAH  HOLTGREWE            PHONE NO : 901 867 4476   5677 AIRLINE RD.                  SE DECISION MADE: 07-OCT-13 ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM PIVOT MEDICAL INC.                510(k) NO: K131769(TRADITIONAL) ATTN: JON  COOK                   PHONE NO : 408 774 1452   247 HUMBOLDT CT                   SE DECISION MADE: 07-OCT-13 SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES THERMOMEDICS INC.                 510(k) NO: K131771(TRADITIONAL) ATTN: PAUL  LIU                   PHONE NO : 886 26625 8188X6134 6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 07-OCT-13 NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESOFLIP BALLOON DILATION CATHETER CROSPON, LTD.                     510(k) NO: K132337(TRADITIONAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   24301 WOODSAGE DRIVE              SE DECISION MADE: 07-OCT-13 BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEM-6221 OMRON HEALTHCARE, INC.            510(k) NO: K131749(TRADITIONAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   24301 WOODSAGE DRIVE              SE DECISION MADE: 07-OCT-13 BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V8 SP NORMAL CONTROL, ABNORMAL CONTROL HELENA LABORATORIES               510(k) NO: K131479(TRADITIONAL) ATTN: JUSTIN  PADIA               PHONE NO : 409 842 3714   1530 LINDBERGH DR.                SE DECISION MADE: 07-OCT-13 BEAUMONT TX 77704                 510(k) STATEMENT

DEVICE: ESTECH COBRA(R) GENESIS BIPOLAR CLAMP ESTECH, INC.                      510(k) NO: K133017(SPECIAL) ATTN: TAMER  IBRAHIM              PHONE NO : 925 543 2110   2603 CAMINO RAMON, STE 100        SE DECISION MADE: 07-OCT-13 SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS PIXIUM 4343RC PHILIPS MEDICAL SYSTEMS DMC GMBH  510(k) NO: K131483(TRADITIONAL) ATTN: JENNIFER  CARTLEDGE         PHONE NO : 864 500 0097   409 WOODRIDGE DR.                 SE DECISION MADE: 07-OCT-13 SENECA SC 29672                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES UNIMED SURGICAL PRODUCTS, INC.    510(k) NO: K132224(TRADITIONAL) ATTN: LEE  ALEXANDER              PHONE NO : 727 546 1900   10401 BELCHER RD.                 SE DECISION MADE: 08-OCT-13 LARGO FL 33777                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER – TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP.        510(k) NO: K131353(TRADITIONAL) ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   56 EAST BELL DRIVE                SE DECISION MADE: 08-OCT-13 WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX KNEE MODULAR TIBIA SYSTEM OMNI LIFE SCIENCE, INC.           510(k) NO: K131472(TRADITIONAL) ATTN: BRANDON  MOLINA             PHONE NO : 774 226 1815   50 O’CONNELL WAY                  SE DECISION MADE: 08-OCT-13 EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R7 CEFLA S.C.                        510(k) NO: K130834(TRADITIONAL) ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 2630   110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 08-OCT-13 ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: WECK EFX ENDO FASCIAL CLOSURE SYSTEM TELEFLEX MEDICAL, INC.            510(k) NO: K132362(TRADITIONAL) ATTN: NATALIE  HICHAK             PHONE NO : 919 361 4071   2917 WECK DR.                     SE DECISION MADE: 08-OCT-13 RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM SYNTHES (USA) PRODUCTS LLC        510(k) NO: K131186(TRADITIONAL) ATTN: REBECCA G REITER            PHONE NO : 610 719 1268   1301 GOSHEN PKWY.                 SE DECISION MADE: 08-OCT-13 WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODESIGN CRANIAL BASE DURAL GRAFT COOK BIOTECH, INC.                510(k) NO: K131015(TRADITIONAL) ATTN: MARY A FADERAN              PHONE NO : 765 497 3355   1425 INNOVATION PLACE             SE DECISION MADE: 08-OCT-13 West Lafayette IN 47906           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDDUSA BIPOLAR SYSTEM ELLIQUENCE LLC                    510(k) NO: K130110(TRADITIONAL) ATTN: OSCAR R PAREDES             PHONE NO : 516 277 9024   2455 Grand Avenue                 SE DECISION MADE: 08-OCT-13 Baldwin NY 11510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INMODE WMBODY DEVICE INMODE MD LTD.                    510(k) NO: K131362(TRADITIONAL) ATTN: AHAVA  STEIN                PHONE NO : 972 976700 02 20 HATA’AS STR., SUITE 102        SE DECISION MADE: 08-OCT-13 KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRONTOSAN WOUND GEL X B. BRAUN MEDICAL, INC.            510(k) NO: K130857(TRADITIONAL) ATTN: NANCY  SKOCYPEC             PHONE NO : 610 266 0500   901 MARCON BLVD.                  SE DECISION MADE: 08-OCT-13 ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS MAQUET CARDIOPULMONARY AG         510(k) NO: K132829(SPECIAL) ATTN: WHITNEY  TORNING            PHONE NO : 973 709 7994   45 BARBOUR POND DRIVE             SE DECISION MADE: 08-OCT-13 WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEL-GE CARE INNOVATIONS QUIETCARE INTEL-GE CARE INNOVATIONS LLC     510(k) NO: K131585(TRADITIONAL) ATTN: MAUREEN  GLYNN              PHONE NO : 916 847 7794   1721 DOUGLAS BLVD SUITE 100       SE DECISION MADE: 08-OCT-13 ROSEVILLE CA 95661                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS BAXTER HEALTHCARE CORP.           510(k) NO: K132734(SPECIAL) ATTN: GARY  CHUMBIMUNE            PHONE NO : 224 270 3312   32650 N WILSON RD.                SE DECISION MADE: 08-OCT-13 ROUND LAKE IL 60073               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132471(SPECIAL) ATTN: SOWMYA  SHETTY              PHONE NO : 901 396 3133   1800 PYRAMID PLACE                SE DECISION MADE: 08-OCT-13 MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) LIFE SPINE, INC                   510(k) NO: K132589(SPECIAL) ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 08-OCT-13 HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NERIA SOFT 90 INFUSION SET UNOMEDICAL A/S                    510(k) NO: K132142(TRADITIONAL) ATTN: DEIRDRE  BARROW             PHONE NO : 440 170952 5256 UNIT B9, TAYLORS COURT, PARKGATE  SE DECISION MADE: 08-OCT-13 ROTHERHAM, SOUTH YORKSHIRE    UK S510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESOPHAGEAL TTS STENT TAEWOONG MEDICAL CO., LTD         510(k) NO: K123205(TRADITIONAL) ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   13417 QUIVAS ST                   SE DECISION MADE: 09-OCT-13 WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE CONVERTIBLE GLENOID BIOMET MANUFACTURING, INC.        510(k) NO: K130390(TRADITIONAL) ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574 267 6639   56 EAST BELL DR.                  SE DECISION MADE: 09-OCT-13 WARSAW IN 46580 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROLLINS 7 OXYGEN MASK ROLLINS MEDICAL SOLUTIONS, INC.   510(k) NO: K130379(TRADITIONAL) ATTN: E. J SMITH                  PHONE NO : 888 729 9674   1468 HARWELL AVE.                 SE DECISION MADE: 09-OCT-13 CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER SURGICAL INSTRUMENT ENGINEERING AG510(k) NO: K131207(TRADITIONAL) ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   33 GOLDEN EAGLE LANE              SE DECISION MADE: 09-OCT-13 LITTLETON CO 80127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW BIOMET                            510(k) NO: K132704(TRADITIONAL) ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   56 EAST BELL DR. P.O BOX 587      SE DECISION MADE: 09-OCT-13 WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGY ODM TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K132667(TRADITIONAL) ATTN: MAUREEN  O’CONNELL          PHONE NO : 978 207 1245   5 TIMBER LANE                     SE DECISION MADE: 09-OCT-13 NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS PLAYTEX MANUFACTURING INC.        510(k) NO: K132819(SPECIAL) ATTN: PUSHPA  RAO                 PHONE NO : 201 785 8070   75 COMMERCE DR.                   SE DECISION MADE: 09-OCT-13 ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEZANNE II INTERBODY FUSION SYSTEM ACCEL SPINE                       510(k) NO: K131981(TRADITIONAL) ATTN: LISA  PETERSON              PHONE NO : 512 507 0746   14901 QUORUM DR. STE. 125         SE DECISION MADE: 09-OCT-13 DALLAS TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AU BICARBONATE REAGENT BECKMAN COULTER IRELAND INC       510(k) NO: K131546(TRADITIONAL) ATTN: DAVID G DAVIS               PHONE NO : 469 236 8180   250 S. KRAEMER BLVD. E1.SE.01     SE DECISION MADE: 09-OCT-13 BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-G5 HAMILTON MEDICAL AG               510(k) NO: K131774(TRADITIONAL) ATTN: RALPH  AGUILA               PHONE NO : 41 91 6606845 VIA CRUSCH 8                      SE DECISION MADE: 09-OCT-13 BONADUZ, GRISONS    SZ 7402       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARUS CONNECT ACUMED LLC                        510(k) NO: K131636(TRADITIONAL) ATTN: BRITTANY  CUNNINGHAM        PHONE NO : 503 207 1467   5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 10-OCT-13 HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K131662(ABBREVIATED) ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   511 BENEDICT AVE.                 SE DECISION MADE: 10-OCT-13 TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEERSCOPE SYSTEM ENDOCHOICE, INC.                  510(k) NO: K131422(TRADITIONAL) ATTN: TAMAR  FUERST               PHONE NO : 972 4 6327731 2 HATOCHEN ST., BUSINESS AND INDUSSE DECISION MADE: 10-OCT-13 CAESAREA    IS 38900              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 TIBIAL NAILING SYSTEM STRYKER TRAUMA AG                 510(k) NO: K131365(TRADITIONAL) ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   325 CORPORATE DRIVE               SE DECISION MADE: 10-OCT-13 MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA SMITH & NEPHEW, INC.              510(k) NO: K130728(TRADITIONAL) ATTN: SAMEER  MANSOUR             PHONE NO : 901 399 5579   7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 10-OCT-13 CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INERTIA MIS PEDICLE SCREW SYSTEM NEXXT SPINE LLC                   510(k) NO: K132412(SPECIAL) ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 10-OCT-13 WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDYS LIF CAGES CLARIANCE                         510(k) NO: K131178(TRADITIONAL) ATTN: JANICE M HOGAN, ESQ.        PHONE NO : 267 675 4611   1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 10-OCT-13 PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLANET SPINE SYSTEM IMPLANET S.A.                     510(k) NO: K132303(TRADITIONAL) ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 10-OCT-13 PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE CONNECTED HEALTH SYSTEM NXSTAGE MEDICAL, INC.             510(k) NO: K131739(TRADITIONAL) ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   350 Merrimack St                  SE DECISION MADE: 10-OCT-13 LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOLOX(R) DELTA CERAMIC HEADS BIOMET, INC.                      510(k) NO: K131684(TRADITIONAL) ATTN: BECKY  EARL                 PHONE NO : 574 372 1518   56 EAST BELL DR. BOX 587          SE DECISION MADE: 10-OCT-13 WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELTEX MEDICAL CARDIOQ-EDM+ DELTEX MEDICAL LIMITED            510(k) NO: K132139(TRADITIONAL) ATTN: RONALD S WARREN             PHONE NO : 858 753 1961   11440 W. BERNARDO CT. SUITE 300   SE DECISION MADE: 10-OCT-13 SAN DIEGO CA 92127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL                  510(k) NO: K132482(SPECIAL) ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   18 Technology Dr Ste 169          SE DECISION MADE: 10-OCT-13 Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3B LASER NEEDLE LIVETEC GMBH                      510(k) NO: K131797(TRADITIONAL) ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   33 GOLDEN EAGLE LANE              SE DECISION MADE: 10-OCT-13 LITTLETON CO 80127                510(k) STATEMENT

DEVICE: THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN MEDICAL PRODUCTS, LLC             510(k) NO: K131023(TRADITIONAL) ATTN: DAVID  MCGILL               PHONE NO : 317 432 5114   7437 OAKLANDON RD.                SE DECISION MADE: 11-OCT-13 INDIANAPOLIS IN 46236             510(k) STATEMENT

DEVICE: BASIC AND DOMINANT FLEX SUCTION PUMPS MEDELA AG                         510(k) NO: K130123(TRADITIONAL) ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   W324S3649 COUNTY ROAD E           SE DECISION MADE: 11-OCT-13 DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON S2000 AND S3000 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130881(TRADITIONAL) ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   1230 SHOREBIRD WAY                SE DECISION MADE: 11-OCT-13 MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PPA/BT-RB STETHOSCOPE RNK PRODUCTS, INC.                510(k) NO: K132405(TRADITIONAL) ATTN: CHARLES R ABBRUSCATO        PHONE NO : 321 610 3980   8247 Devereux Dr Ste 101          SE DECISION MADE: 11-OCT-13 Melbourne FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDICOR CPAM WITH SDB (SINGLE SENSOR) INOVISE MEDICAL, INC.             510(k) NO: K130660(TRADITIONAL) ATTN: EARL  ANDERSON              PHONE NO : 503 431 3800   8770 SW NIMBUS AVE. SUITE D       SE DECISION MADE: 11-OCT-13 Beaverton OR 97008                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE MEDICAL MICROCATHETER REVERSE MEDICAL CORPORATION       510(k) NO: K130858(TRADITIONAL) ATTN: JEFFREY  VALKO              PHONE NO : 949 215 0660   13700 ALTON PARKWAY SUITE 167     SE DECISION MADE: 11-OCT-13 IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC.          510(k) NO: K131437(TRADITIONAL) ATTN: CHRISTINA  ROWE             PHONE NO : 510 413 2486   301 E. EVELYN AVE.                SE DECISION MADE: 11-OCT-13 MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLASSIC INTERMITTENT CATHETER FLEXICARE MEDICAL LTD.            510(k) NO: K132619(TRADITIONAL) ATTN: CHRISTOPHER  WATKINS        PHONE NO : 44 1443 474560 CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 11-OCT-13 MID GLAMORGAN    UK CF45 4ER      510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: MTM(R) CLEAR ALIGNER DENTSPLY INTERNATIONAL, INC.      510(k) NO: K132145(TRADITIONAL) ATTN: HELEN  LEWIS                PHONE NO : 717 487 1332   SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 11-OCT-13 YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCP-USB STETHOSCOPE RNK PRODUCTS, INC.                510(k) NO: K132560(TRADITIONAL) ATTN: CHARLES R ABBRUSCATO        PHONE NO : 621 610 3980   8247 Devereux Dr Ste 101          SE DECISION MADE: 11-OCT-13 Melbourne FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K131807(TRADITIONAL) ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   3100 HANSEN WAY                   SE DECISION MADE: 11-OCT-13 PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC.         510(k) NO: K131677(TRADITIONAL) ATTN: JOHN  MCINTYRE              PHONE NO : 949 837 3600   13900 ALTON PKWY STE 123          SE DECISION MADE: 11-OCT-13 IRVINE CA 92618 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK INCORPORATED                 510(k) NO: K132885(SPECIAL) ATTN: SEAN  SPENCE                PHONE NO : 812 335 3575   750 DANIELS WAY                   SE DECISION MADE: 11-OCT-13 BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KATANA ZIRCONIA KURARAY NORITAKE DENTAL INC.      510(k) NO: K131534(TRADITIONAL) ATTN: IVAN  WASSERMAN             PHONE NO : 202 585 6529   700 12TH ST SW SUITE 100          SE DECISION MADE: 11-OCT-13 WASHINGTON DC 20005               510(k) STATEMENT

DEVICE: BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA ORTHO DEVELOPMENT CORP.           510(k) NO: K131337(TRADITIONAL) ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 11-OCT-13 DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K131908(TRADITIONAL) ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   920 WINTER STREET                 SE DECISION MADE: 11-OCT-13 WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEATTLE – PAP SEATTLE CHILDRENS HOSPITAL        510(k) NO: K131502(TRADITIONAL) ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   1900 NINTH AVENUE                 SE DECISION MADE: 11-OCT-13 SEATTLE WA 98101                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC.                    510(k) NO: K132161(TRADITIONAL) ATTN: PATRICK  HUGHES             PHONE NO : 352 327 4762   2320 N.W. 66TH CT.                SE DECISION MADE: 11-OCT-13 GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT INFRARED THERMOMETER JINXINBAO ELECTRONIC CO.,LTD      510(k) NO: K130231(ABBREVIATED) ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182 ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 15-OCT-13 WENZHOU, ZHEJIANG    CH 325000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) BRONCUS MEDICAL INC               510(k) NO: K131234(TRADITIONAL) ATTN: MAHTAB  FATEMI              PHONE NO : 650 428 1600   1400 N. Shoreline Blvd., Bldg A, SSE DECISION MADE: 15-OCT-13 Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: ENDOCHOICE HOT BIOPSY FORCEPS ENDOCHOICE, INC.                  510(k) NO: K131991(TRADITIONAL) ATTN: DANIEL  HOEFER              PHONE NO : 678 708 4743   11810 WILLS ROAD                  SE DECISION MADE: 15-OCT-13 ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM U TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K131993(ABBREVIATED) ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959   325 BIG ELM ST.                   SE DECISION MADE: 15-OCT-13 HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NASAL COMFORT FREEDOM LAKEVIEW SLEEP CENTER             510(k) NO: K130686(TRADITIONAL) ATTN: ANDY  BLACK                 PHONE NO : 847 620 7990   400 NORTH RAND RD                 SE DECISION MADE: 16-OCT-13 NORTH BARRINGTON IL 60010         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROW FUSION NLT SPINE LTD                     510(k) NO: K130254(TRADITIONAL) ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794   555 THIRTEENTH STREET NW          SE DECISION MADE: 16-OCT-13 WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVATION 10/12 HIP STEM ORTHO DEVELOPMENT CORP.           510(k) NO: K131022(TRADITIONAL) ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 16-OCT-13 DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS TORNIER SAS                       510(k) NO: K131231(TRADITIONAL) ATTN: SEVERINE  BONNETON          PHONE NO : 003 347 6613500 161 RUE LAVOISIER                 SE DECISION MADE: 16-OCT-13 MONTBONNOT SAINT MARTIN    FR 3833510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE SUCTION COAGULATOR MEDLINE INDUSTRIES, INC.          510(k) NO: K122949(TRADITIONAL) ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   ONE MEDLINE PLACE                 SE DECISION MADE: 16-OCT-13 MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: PEDIATRIC FOLDING WHEELCHAIR COLUMBIA MEDICAL MFG, LLC         510(k) NO: K130644(ABBREVIATED) ATTN: GARY  WERSCHMIDT            PHONE NO : 562 282 0244   11724 WILLAKE ST                  SE DECISION MADE: 16-OCT-13 SANTA FE SPRINGS CA 90670         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K131047(TRADITIONAL) ATTN: LEI  CHEN                   PHONE NO : 86 10 88794630 NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 16-OCT-13 SHIJINGSHAN DISTRICT, BEIJING    C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAEMAR CARDIOKEY HOLTER RECORDER BRAEMAR MANUFACTURING LLC         510(k) NO: K130294(SPECIAL) ATTN: KENT  SAYLER                PHONE NO : 619 243 7500   750 B. STREET, STUITE 1400        SE DECISION MADE: 16-OCT-13 SAN DIEGO CA 92101                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A.I.M. SUTURE ANCHOR ANCHOR INNOVATION MEDICAL, INC.   510(k) NO: K132461(TRADITIONAL) ATTN: HOWARD L SCHRAYER           PHONE NO : 5410 EDSON LANE SUITE 308         SE DECISION MADE: 16-OCT-13 ROCKVILLE MD 20852                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE TITAN 3T TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132160(TRADITIONAL) ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   2441 MICHELLE DRIVE               SE DECISION MADE: 16-OCT-13 TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: .DECIMAL PROTON APERTURE .DECIMAL, INC.                    510(k) NO: K132236(TRADITIONAL) ATTN: KIMBERLY  RUPP              PHONE NO : 407 330 3300   121 CENTRAL PARK PLACE            SE DECISION MADE: 16-OCT-13 SANFORD FL 32771                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IFUSE IMPLANT SYSTEM SI-BONE, INC.                     510(k) NO: K131405(TRADITIONAL) ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   1171 BARROILHET DR                SE DECISION MADE: 16-OCT-13 HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMOOTH OR THREADED METALLIC BONE FASTENER BIOMEDICAL ENT., INC.             510(k) NO: K131640(TRADITIONAL) ATTN: JOE  SOWARD                 PHONE NO : 210 677 0354   14785 OMICRON DR., SUITE 205      SE DECISION MADE: 16-OCT-13 SAN ANTONIO TX 78245              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF LEGACY MEDICAL, INC.              510(k) NO: K130942(TRADITIONAL) ATTN: DEB  ROBERTSON              PHONE NO : 952 322 7240   9039 Horizon Dr                   SE DECISION MADE: 17-OCT-13 Shakopee MN 55379                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVATION AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K131167(TRADITIONAL) ATTN: JULIE T WING                PHONE NO : 610 984 9147   3773 CORPORATE PARKWAY            SE DECISION MADE: 17-OCT-13 CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER INFRAREDX, INC.                   510(k) NO: K130719(TRADITIONAL) ATTN: STEVE  CHARTIER             PHONE NO : 781 345 9593   34 THIRD AVE                      SE DECISION MADE: 17-OCT-13 BURLINGTON MA 01803               510(k) STATEMENT

DEVICE: INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K131872(SPECIAL) ATTN: MARKUS  STACHA              PHONE NO : 49 7031 4632840 HEWLETT-PACKARD STR.2             SE DECISION MADE: 17-OCT-13 BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUE SPINAL FIXATION SYSTEM INNOVATIVE SURGICAL DESIGNS       510(k) NO: K130958(TRADITIONAL) ATTN: ED  MORRIS                  PHONE NO : 812 774 9297   2660 E. 2ND STREET #10            SE DECISION MADE: 17-OCT-13 BLOOMINGTON IN 47401              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NBM-200MP ORSENSE LTD                       510(k) NO: K124041(TRADITIONAL) ATTN: MARK A HELLER               PHONE NO : 202 346 4107   901 NEW YORK AVE, N.W.            SE DECISION MADE: 17-OCT-13 WASHINGTON DC 20001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOROOT RCS NOVOCOL, INC.                     510(k) NO: K130601(ABBREVIATED) ATTN: CORA  BRACHO-TROCONIS       PHONE NO : 303 665 7535   416 SOUTH TAYLOR AVE.             SE DECISION MADE: 17-OCT-13 LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIGUIDE DELIVERY SYSTEM RESPICARDIA                       510(k) NO: K130378(TRADITIONAL) ATTN: BONNIE  LABOSKY             PHONE NO : 952 540 4470   12400 WHITEWATER DRIVE SUITE 150  SE DECISION MADE: 17-OCT-13 MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE AAP IMPLANTATE AG                 510(k) NO: K131459(TRADITIONAL) ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 49 307501 9193 LORENZWEG 5                       SE DECISION MADE: 17-OCT-13 BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE ETHICON ENDO-SURGERY, LLC         510(k) NO: K132612(TRADITIONAL) ATTN: BRIAN  GODWIN               PHONE NO : 513 337 3623   4545 CREEK ROAD                   SE DECISION MADE: 17-OCT-13 CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSCEND AUTO SOMNETICS INTERNATIONAL, INC.     510(k) NO: K132127(TRADITIONAL) ATTN: MELINDA  SWANSON            PHONE NO : 651 621 1800   33 5TH AVE NW, STE 500            SE DECISION MADE: 17-OCT-13 NEW BRIGHTON MN 55112             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SITE-RITE VISION II ULTRASOUND SYSTEM C.R. BARD, INC.                   510(k) NO: K132942(SPECIAL) ATTN: KERRIE  HAMBLIN             PHONE NO : 801 522 4909   605 NORTH 5600 WEST               SE DECISION MADE: 17-OCT-13 SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM SMITH & NEPHEW, INC.              510(k) NO: K132636(TRADITIONAL) ATTN: KATHLEEN  SOLOMON           PHONE NO : 978 749 1605   150 MINUTEMAN RD.                 SE DECISION MADE: 17-OCT-13 ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL NEURO 3 SYSTEM STRYKER                           510(k) NO: K131775(TRADITIONAL) ATTN: MANISH  PATEL               PHONE NO : 269 388 4271   750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 17-OCT-13 PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP.           510(k) NO: K132430(TRADITIONAL) ATTN: CHRISTOPHER  DACHEL         PHONE NO : 763 494 2718   ONE SCIMED PLACE                  SE DECISION MADE: 17-OCT-13 MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAPPHIRE INFUSION PUMP Q CORE MEDICAL LTD                510(k) NO: K123049(TRADITIONAL) ATTN: RHONA  SHANKER              PHONE NO : 301 251 9570   12154 DARNESTOWN ROAD #236        SE DECISION MADE: 17-OCT-13 GAITHERBURG MD 20878              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMNOLYZER 24X7 RESPIRONICS, INC.                 510(k) NO: K131994(TRADITIONAL) ATTN: DANIELA  AIZPITARTE         PHONE NO : 724 387 7954   1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 17-OCT-13 MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGENET 5 PC SOFTWARE SYSTEM TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K132438(TRADITIONAL) ATTN: MAUREEN  O’CONNELL          PHONE NO : 978 207 1245   5 TIMBER LANE                     SE DECISION MADE: 17-OCT-13 NORTH READING MA 01864            510(k) STATEMENT

DEVICE: GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION GLOOKO, INC.                      510(k) NO: K132272(SPECIAL) ATTN: SHILPA  MYDUR               PHONE NO : 650 720 5310   170A UNIVERSITY AVENUE            SE DECISION MADE: 17-OCT-13 PALO ALTO CA 94301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS           510(k) NO: K130684(TRADITIONAL) ATTN: NANCY  BURKE                PHONE NO : 425 487 7000   22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 18-OCT-13 BOTHELL WA 98041 3003             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASA ORAL APPLIANCES AMERICAN SLEEP ASSOCIATION        510(k) NO: K130504(TRADITIONAL) ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   PO BOX 566                        SE DECISION MADE: 18-OCT-13 CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS BIOMET SPORTS MEDICINE            510(k) NO: K122437(TRADITIONAL) ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 18-OCT-13 WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRANIAL MAP NEURO STRYKER CORPORATE                 510(k) NO: K131214(TRADITIONAL) ATTN: LILIAN  ECKERT              PHONE NO : 49 761 4512117 BOETZINGER STR. 41                SE DECISION MADE: 18-OCT-13 FREIBURG, BADEN-WUERTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY ROCHE DIAGNOSTICS                 510(k) NO: K132571(TRADITIONAL) ATTN: KELLI  TURNER               PHONE NO : 317 521 4515   9115 HAGUE ROAD                   SE DECISION MADE: 18-OCT-13 INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS BOSTON SCIENTIFIC CORP.           510(k) NO: K132947(SPECIAL) ATTN: MAUREEN  SUNDEEN            PHONE NO : 763 494 2903   ONE SCIMED PLACE                  SE DECISION MADE: 18-OCT-13 MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFUNCTIONAL SERIES BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131859(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 18-OCT-13 SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK ETHICON ENDO-SURGERY, LLC         510(k) NO: K131663(TRADITIONAL) ATTN: CHRISTINA  CANTER           PHONE NO : 513 337 7321   4545 CREEK ROAD                   SE DECISION MADE: 18-OCT-13 CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMSTAR AUTO A-FLEX HT RESPIRONICS, INC.                 510(k) NO: K131982(SPECIAL) ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 18-OCT-13 MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LENSTEC LC INJECTION SYSTEM LENSTEC, INC.                     510(k) NO: K122848(TRADITIONAL) ATTN: JIMMY  CHACKO               PHONE NO : 727 571 2272   1765 Commerce Ave N               SE DECISION MADE: 18-OCT-13 Saint Petersburg FL 33716         510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: PROVOX VEGA PUNCTURE SET ATOS MEDICAL AB                   510(k) NO: K131947(TRADITIONAL) ATTN: FERENC  DAHNER              PHONE NO : 46 415198 00 KRAFTGATAN 8                      SE DECISION MADE: 18-OCT-13 HORBY    SW SE-24222              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER OLYMPUS SURGICAL TECHNOLOGIES AMER510(k) NO: K132181(TRADITIONAL) ATTN: NEIL  KELLY                 PHONE NO : 908 804 2600   136 TURNPIKE ROAD                 SE DECISION MADE: 21-OCT-13 SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEO DENTA ZIRCONIA NEO GROUP LIMITED                 510(k) NO: K130198(TRADITIONAL) ATTN: MIKE  ADAMS                 PHONE NO : 852 235 69700 ROOM Q1D G/F, KAISER EST 3RD PHASESE DECISION MADE: 21-OCT-13 HUNG HOM, KOWLOON    HK HK 852    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM PURITAN MEDICAL PRODUCTS LLC      510(k) NO: K131630(TRADITIONAL) ATTN: MEHDI  KARAMCHI             PHONE NO : 207 876 3311   31 SCHOOL STREET P.O. BOX 149     SE DECISION MADE: 21-OCT-13 GUILFORD ME 04443                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWIFT AIR RESMED LTD.                       510(k) NO: K132013(TRADITIONAL) ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 21-OCT-13 SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LESSER METATARSAL HEAD IMPLANT SYSTEM SOLANA SURGICAL, LLC              510(k) NO: K131187(TRADITIONAL) ATTN: JOE  CLIFT                  PHONE NO : 901 818 1860   6363 POPLAR AVENUE SUITE 312      SE DECISION MADE: 22-OCT-13 MEMPHIS TN 38119                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIFLUX SYSTEM 6000 PERIMED AB                        510(k) NO: K131253(ABBREVIATED) ATTN: MARIA  LILJEVRET            PHONE NO : 46 8 58011990 DATAVAGEN 9 A                     SE DECISION MADE: 22-OCT-13 JARFALLA    SE 17543              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANFAC BONE MARROW ASPIRATION NEEDLE RANFAC CORP.                      510(k) NO: K131157(TRADITIONAL) ATTN: CHRISTOPHER P WHELAN        PHONE NO : 508 588 4400   30 Doherty Avenue, P.O. Box 635 AvSE DECISION MADE: 22-OCT-13 Avon MA 02322                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDCOMP VASCU-PICC WITH VALVE MEDCOMP (MEDICAL COMPONENTS)      510(k) NO: K130897(TRADITIONAL) ATTN: JESSICA  LEO                PHONE NO : 215 256 4201   1499 DELP DRIVE                   SE DECISION MADE: 22-OCT-13 HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER MEDTRONIC INC.                    510(k) NO: K132673(SPECIAL) ATTN: HEATHER  MOROSE             PHONE NO : 978 739 3187   37A CHERRY HILL DRIVE             SE DECISION MADE: 22-OCT-13 DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133128(ABBREVIATED) ATTN: ASHA  GARTLAND              PHONE NO : 914 524 3257   511 BENEDICT AVE.                 SE DECISION MADE: 22-OCT-13 TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAUTONA INJECTOR DEVICE TAUTONA GROUP, LLC                510(k) NO: K131963(TRADITIONAL) ATTN: JOE  RIMSA                  PHONE NO : 650 331 2450   4040 CAMPBELL AVE, STE 110        SE DECISION MADE: 22-OCT-13 MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP.           510(k) NO: K132990(SPECIAL) ATTN: DIANE  NELSON               PHONE NO : 763 255 0813   ONE SCIMED PLACE                  SE DECISION MADE: 22-OCT-13 MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM S PLUS / S PLUS (ASSAYED) TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K132751(ABBREVIATED) ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959   325 BIG ELM ST.                   SE DECISION MADE: 22-OCT-13 HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEM FLOW COUPLER DEVICE AND SYSTEM SYNOVIS LIFE TECHNOLOGIES, INC.   510(k) NO: K132727(SPECIAL) ATTN: TROY  THOME                 PHONE NO : 651 796 7300   2575 UNIVERSITY AVE., STE.180     SE DECISION MADE: 22-OCT-13 ST. PAUL MN 55114 1024            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS SMITH & NEPHEW, INC.              510(k) NO: K132435(TRADITIONAL) ATTN: MEGAN  FESSENDEN            PHONE NO : 901 399 1104   7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 22-OCT-13 CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISCOELASTIC INJECTOR SIGHT SCIENCES, INC.              510(k) NO: K132494(TRADITIONAL) ATTN: JUDY F GORDON D.V.M.        PHONE NO : 949 715 0609   733 BOLSANA DRIVE                 SE DECISION MADE: 22-OCT-13 LAGUNA BEACH CA 92651             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALIX LUMBAR SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC              510(k) NO: K131350(TRADITIONAL) ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   452 Alexandersville Rd            SE DECISION MADE: 23-OCT-13 Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTUM TELEHEALTH APPLICATION OPTUMHEALTH CARE SOLUTIONS, INC.  510(k) NO: K130971(TRADITIONAL) ATTN: ROSHANA  AHMED, MA, RAC     PHONE NO : 905 690 5792 4 INNOVATION DR                   SE DECISION MADE: 23-OCT-13 DUNDAS, ON    CA L9H 7P3          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE SMITH & NEPHEW, INC.              510(k) NO: K132446(SPECIAL) ATTN: LAURA  REYNOLDS             PHONE NO : 727 399 7702   970 LAKE CARILLON DR. SUITE 110   SE DECISION MADE: 23-OCT-13 ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAGEN WOUND DRESSING KERECIS LIMITED                   510(k) NO: K132343(TRADITIONAL) ATTN: GUDMUNDUR F SIGURJONSSON    PHONE NO : 354 562 2601 EYRARGATA 2                       SE DECISION MADE: 23-OCT-13 ISAFIJORDUR    IC 400             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WMT IMPLANTABLE K-WIRE WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K132895(TRADITIONAL) ATTN: LESLIE  FITCH               PHONE NO : 901 867 4409   5677 AIRLINE RD.                  SE DECISION MADE: 23-OCT-13 ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD.        510(k) NO: K132627(SPECIAL) ATTN: SELINA  QIAN                PHONE NO : 86 0513 80580116 NO.8, Tongxing Road, Nantong EconoSE DECISION MADE: 23-OCT-13 NANTONG, JIANGSU    CH 226009     510(k) STATEMENT

DEVICE: EVOLUTION MP ADAPTIVE PS TIBIAL INSERT WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K131679(TRADITIONAL) ATTN: THERESA  LEISTER            PHONE NO : 901 290 5898   5677 AIRLINE RD.                  SE DECISION MADE: 23-OCT-13 ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS           510(k) NO: K131590(TRADITIONAL) ATTN: CHRISTINE  TREFETHEN        PHONE NO : 978 659 3890   3000 Minuteman Rd                 SE DECISION MADE: 23-OCT-13 ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAMESH -CICAT FEG TEXTILTECHNIK FORSCHUNGS-UND E510(k) NO: K131530(TRADITIONAL) ATTN: NEIL R ARMSTRONG            PHONE NO : 011 44 1763222505 HERLINGTON HOUSE, ORTON MALBORNE  SE DECISION MADE: 23-OCT-13 PETERBOROUGH, CAMBS.    UK PE2 5XS510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX CSF CONTROLS LEVELS 2 AND 3 RANDOX LABORATORIES, LTD.         510(k) NO: K132156(TRADITIONAL) ATTN: PAULINE  ARMSTRONG          PHONE NO : 028 944 22413 55 DIAMOND RD.                    SE DECISION MADE: 23-OCT-13 CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIAX 2 SYSTEM STRYKER TRAUMA AG                 510(k) NO: K132502(TRADITIONAL) ATTN: ELIJAH N WREH               PHONE NO : 201 3 5691   325 CORPORATE DR                  SE DECISION MADE: 23-OCT-13 MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN LLC                      510(k) NO: K132493(SPECIAL) ATTN: KATHERINE  KASSIM           PHONE NO : 203 492 5299   60 MIDDLETOWN AVENUE              SE DECISION MADE: 23-OCT-13 NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOTUS SPINAL ELEMENTS, INC.             510(k) NO: K131427(TRADITIONAL) ATTN: BENJAMIN A KIMBALL          PHONE NO : 760 607 1816   3115 MELROSE DRIVE STE 200        SE DECISION MADE: 24-OCT-13 CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPRO – INFINITY PLATE ANCHOR SYSTEM BIOPRO, INC.                      510(k) NO: K132510(TRADITIONAL) ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   3150 E. 200TH ST                  SE DECISION MADE: 24-OCT-13 PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS CORE 3D PROTECH, S.L.             510(k) NO: K122295(ABBREVIATED) ATTN: ANNA  CORTINA               PHONE NO : 349 022828 48 POL. IND. SANTA ANNA APARTAT 20   SE DECISION MADE: 24-OCT-13 SANTPEDOR    SP 08251             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAK OSS FEMORAL KNEE COMPONENTS BIOMET ORTHOPEDICS CORP.          510(k) NO: K131393(TRADITIONAL) ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   56 EAST BELL DRIVE                SE DECISION MADE: 24-OCT-13 WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON S1000 / S2000 / S3000 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132804(TRADITIONAL) ATTN: CHRISTINE  DUNN             PHONE NO : 685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 24-OCT-13 MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: OMBRA TABLE TOP COMPRESSOR TRUDELL MEDICAL INTL.             510(k) NO: K131881(TRADITIONAL) ATTN: DARRYL  FISCHER             PHONE NO : 519 455 7060 725 THIRD ST.                     SE DECISION MADE: 24-OCT-13 LONDON    CA N5V 5G4              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACEM ULTRADENT PRODUCTS INC. / ORATECH 510(k) NO: K132255(TRADITIONAL) ATTN: DIANE E ROGER               PHONE NO : 801 553 4491   10200 SOUTH 505 WEST              SE DECISION MADE: 24-OCT-13 SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION              510(k) NO: K132338(SPECIAL) ATTN: ERICA  LI                   PHONE NO : 886 3359 6268 X8672 3F,6F, No.252, Shangying Road, GuiSE DECISION MADE: 24-OCT-13 Taoyuan County    TW 33341        510(k) STATEMENT

DEVICE: SHEATHLESS EAUCATH CORONARY GUIDE CATHETER ASAHI INTECC CO., LTD.            510(k) NO: K132556(TRADITIONAL) ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   2500 RED HILL AVE, SUITE 210      SE DECISION MADE: 24-OCT-13 SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RIGHTEST CONTROL SOLUTION BIONIME CORPORATION               510(k) NO: K133003(TRADITIONAL) ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 24-OCT-13 GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT CHURCH & DWIGHT CO., INC.         510(k) NO: K131887(TRADITIONAL) ATTN: EMILY  PEREZ                PHONE NO : 609 806 1430   500 CHARLES EWING BLVD            SE DECISION MADE: 24-OCT-13 EWING NJ 08628                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: (QUANTA SYSTEM) SURGICAL LASER FIBERS QUANTA SYSTEM, S.P.A.             510(k) NO: K131473(TRADITIONAL) ATTN: MAURIZIO  BIANCHI           PHONE NO : 39 0331 376797 VIA IV NOVEMBRE,116               SE DECISION MADE: 24-OCT-13 SOLBIATE OLONA    IT 21058        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K131895(TRADITIONAL) ATTN: BRETT  WHISTON              PHONE NO : 64 9 5740100 15 MAURICE PAYKEL PLACE           SE DECISION MADE: 24-OCT-13 EAST TAMAKI    NZ 2013            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIA FAN SYSTEM TRIA BEAUTY, INC.                 510(k) NO: K130459(TRADITIONAL) ATTN: JONATHAN  KAHAN             PHONE NO : 202 638 5794   555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 25-OCT-13 WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY BIO-RAD LABORATORIES              510(k) NO: K132227(TRADITIONAL) ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   9500 JERONIMO RD.                 SE DECISION MADE: 25-OCT-13 IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN                          510(k) NO: K130904(TRADITIONAL) ATTN: JENNIFER  SULLIVAN          PHONE NO : 508 452 1659   15 HAMPSHIRE STREET               SE DECISION MADE: 25-OCT-13 MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOLIGHT BIODYNAM BIOLIGHT AB                       510(k) NO: K130866(SPECIAL) ATTN: PAR OLAUSSON  LIDO          PHONE NO : 46 0 86225270 WARFVINGES VAG 26                 SE DECISION MADE: 25-OCT-13 STOCKHOLM    SW SE 112 51         510(k) STATEMENT

DEVICE: COVAMESH BIOMUP S.A.                       510(k) NO: K130428(TRADITIONAL) ATTN: VALERIE  CENTIS             PHONE NO : 33 04 86573610 8 ALLEE IRENE JOLIOT-CURIE        SE DECISION MADE: 25-OCT-13 ST-PRIEST    FR 69800             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOSPEED PROFILE EV DENTSPLY IMPLANTS MANUFACTURING GM510(k) NO: K130999(TRADITIONAL) ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   12264 EL CAMINO REAL, SUITE 400   SE DECISION MADE: 25-OCT-13 SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAUMEDIC-PTO-MONITORING-SYSTEM RAUMEDIC AG                       510(k) NO: K130529(TRADITIONAL) ATTN: REINER  THIEM               PHONE NO : 004 992523 592782 HERRMANN-STAUDINGER-STR. 2        SE DECISION MADE: 25-OCT-13 HELMBRECHTS    GM 95233           510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: MIRADRY SYSTEM MIRAMAR LABS, INC.                510(k) NO: K131162(TRADITIONAL) ATTN: KATHY  O’SHAUGHNESSY        PHONE NO : 408 940 8700   445 INDIO WAY                     SE DECISION MADE: 25-OCT-13 SUNNYVALE CA 94085 4203           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133124(ABBREVIATED) ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   511 BENEDICT AVE.                 SE DECISION MADE: 25-OCT-13 TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM INTELLIGENT IMPLANT SYSTEMS, LLC  510(k) NO: K132900(TRADITIONAL) ATTN: MICHAEL  NUTT               PHONE NO : 704 424 1009   3300 INTERNATIONAL AIRPORT DRIVE SSE DECISION MADE: 25-OCT-13 CHARLOTTE NC 28208                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOGRAPHY VIEWER SMV658 FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K132188(TRADITIONAL) ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   419 WEST AVE.                     SE DECISION MADE: 25-OCT-13 STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDUSA VASCULAR PLUG ENDOSHAPE, INC.                   510(k) NO: K123696(TRADITIONAL) ATTN: MICHAEL  PARMENTER          PHONE NO : 303 951 6898   2450 Central Ave Ste I            SE DECISION MADE: 25-OCT-13 Boulder CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC.                        510(k) NO: K132020(SPECIAL) ATTN: STEVEN  LAWRIE              PHONE NO : 812 335 3575   750 DANIELS WAY P.O. BOX 489      SE DECISION MADE: 25-OCT-13 BLOOMINGTON IN 47402              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTINCT ENDOSCOPIC HEMOCLIP WILSON-COOK MEDICAL INC.          510(k) NO: K132809(SPECIAL) ATTN: SCOTTIE  FARIOLE            PHONE NO : 336 744 0157   4900 Bethania Station Rd          SE DECISION MADE: 25-OCT-13 Winston Salem NC 27105            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED INSTRUMENTATIONS, INC.   510(k) NO: K132059(TRADITIONAL) ATTN: JORGE  MILLAN               PHONE NO : 305 925 1260   601 WEST 20TH STREET              SE DECISION MADE: 25-OCT-13 HIALEAH FL 33010                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TX WHEELCHAIR CHASSIS JCM SEATING SOLUTIONS LTD         510(k) NO: K131336(TRADITIONAL) ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   816 CONGRESS AVE. SUITE 1400      SE DECISION MADE: 28-OCT-13 AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: JIAJIAN POINTOSELECT DIGITAL WUXI JIANJIAN MEDICAL INSTRUMENT C510(k) NO: K123958(TRADITIONAL) ATTN: DORIS  DONG                 PHONE NO : 86 21 31261348 RM 1706, NO. 128 SONGLE RD. SONGJISE DECISION MADE: 28-OCT-13 SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAUTILUS SPINAL SYSTEM LIFE SPINE, INC                   510(k) NO: K132866(TRADITIONAL) ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 28-OCT-13 HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K131446(TRADITIONAL) ATTN: STEPHANIE N SHEESLEY        PHONE NO : 717 840 3522   589 DAVIES DRIVE                  SE DECISION MADE: 28-OCT-13 YORK PA 17402                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE MEDTRONIC, INC.                   510(k) NO: K132972(SPECIAL) ATTN: JULIA A NELSON              PHONE NO : 763 514 9844   7611 NORTHLAND DRIVE              SE DECISION MADE: 28-OCT-13 MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM SPECTRUM SPINE, LLC               510(k) NO: K132126(TRADITIONAL) ATTN: OTTIE  PENDLETON            PHONE NO : 404 372 0389   100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 28-OCT-13 WAXHAW NC 28173                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MICRO VENTION, INC.               510(k) NO: K132083(TRADITIONAL) ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   1311 VALENCIA AVENUE              SE DECISION MADE: 28-OCT-13 TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITCLAMP 50 INNOVATIVE TRAUMA CARE INC        510(k) NO: K132651(TRADITIONAL) ATTN: RICHARD  WAITE              PHONE NO : 210 582 5850   3463 MAGIC DR. SUITE 120          SE DECISION MADE: 28-OCT-13 SAN ANTONIO TX 78229              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYPATCH DMS-SERVICE LLC                   510(k) NO: K131190(TRADITIONAL) ATTN: LYNDA S COLE                PHONE NO : 775 315 0660   2800 NEILSON WAY, STE. 1          SE DECISION MADE: 29-OCT-13 SANTA MONICA CA 90405             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRATION VENTILATOR SYSTEM 5I/7I EVENT MEDICAL LTD                 510(k) NO: K130178(TRADITIONAL) ATTN: RICK  WATERS                PHONE NO : 949 492 8312   971CALLE AMANECER SUITE 101       SE DECISION MADE: 29-OCT-13 SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WOUNDWASH SALINE SPRAY NEILMED PHARMACEUTICALS, INC.     510(k) NO: K123910(TRADITIONAL) ATTN: KETAN  MEHTA                PHONE NO : 707 525 3784   601 AVIATION BLVD.                SE DECISION MADE: 29-OCT-13 SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2.5MM INLINE FUSION PLATE BIOMET, INC.                      510(k) NO: K131867(TRADITIONAL) ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   56 EAST BELL DR. BOX 587          SE DECISION MADE: 29-OCT-13 WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS NETWORK MEDICAL PRODUCTS, LTD.    510(k) NO: K130117(TRADITIONAL) ATTN: ALISON  MARCH               PHONE NO : 440 176560 955 Coronet House, Kearsley Road      SE DECISION MADE: 29-OCT-13 Ripon    UK HG4 2SG               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD.510(k) NO: K130274(TRADITIONAL) ATTN: JOHN  O’TOOLE               PHONE NO : 27 12 3860012 184 BESSEMER ROAD                 SE DECISION MADE: 29-OCT-13 PRETORIA WEST INDU., GAUTENG    SF510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK ENCORE MEDICAL, L.P.              510(k) NO: K130048(TRADITIONAL) ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   9800 METRIC BLVD.                 SE DECISION MADE: 29-OCT-13 AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDOR BIORESORBABLE MATRIX BARRIER SUNSTAR AMERICAS, INC.            510(k) NO: K132325(ABBREVIATED) ATTN: DEBORAH L GRAYESKI          PHONE NO : 202 550 7395   575 8TH AVE, STE 1212             SE DECISION MADE: 29-OCT-13 NEW YORK NY 10018                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIPLOMAT DIPLOMAT DENTAL S.R.O.            510(k) NO: K130534(TRADITIONAL) ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   816 CONGRESS AVENUE, SUITE 1400   SE DECISION MADE: 30-OCT-13 AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIROTEL MIR MEDICAL INTL. RESEARCH SRL    510(k) NO: K130784(SPECIAL) ATTN: GERDA  VAN HOUTS            PHONE NO : 39 06 22754777 VIA DEL MAGGIOLINO 125            SE DECISION MADE: 30-OCT-13 ROMA    IT 00155                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUNTOUCH EYE SPEAR HUIZHOU FORYOU MEDICAL DEVICES CO,510(k) NO: K132796(TRADITIONAL) ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850 P.O. BOX 120-119                  SE DECISION MADE: 30-OCT-13 SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW ULTRATAPE SMITH & NEPHEW, INC.              510(k) NO: K132357(SPECIAL) ATTN: MELODY  BI                  PHONE NO : 508 337 4035   150 MINUTEMAN RD.                 SE DECISION MADE: 30-OCT-13 ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS AJW TECHNOLOGY CONSULTANTS, INC.  510(k) NO: K131893(TRADITIONAL) ATTN: JANET  DOUGLAS              PHONE NO : 813 645 2855   445 APOLLO BEACH BLVD             SE DECISION MADE: 30-OCT-13 APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWER BONE SCREW SET FLOWER ORTHOPEDICS CORPORATION    510(k) NO: K132248(TRADITIONAL) ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 30-OCT-13 PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS MEDICAL DEVICES (PVT) LTD.        510(k) NO: K131719(TRADITIONAL) ATTN: TAUSEEF  AJMAL              PHONE NO : 009 252357 1214 WAZIRABAD RD.                     SE DECISION MADE: 30-OCT-13 UGOKI-SIALKOT    PK PK            510(k) STATEMENT

DEVICE: MULTIVIEW HOLOGIC, INC.                     510(k) NO: K132316(TRADITIONAL) ATTN: EILEEN M BOYLE              PHONE NO : 781 999 7781   35 CROSBY DR.                     SE DECISION MADE: 30-OCT-13 BEDFORD MA 01730                  510(k) STATEMENT

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DEVICE: MESO BILAYER SURGICAL MESH KENSEY NASH CORPORATION DBA DSM BI510(k) NO: K132025(TRADITIONAL) ATTN: SUSAN  PILEGGI              PHONE NO : 484 713 2173   735 PENNSYLVANIA DRIVE            SE DECISION MADE: 30-OCT-13 EXTON PA 19341                    510(k) SUMMARY AVAILABLE FROM FDA

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