Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

October 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2013


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: HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
ETHICON ENDO-SURGERY, LLC         510(k) NO: K132512(SPECIAL)
ATTN: DAVID  LOCKE                PHONE NO : 513 337 1281   
4545 CREEK RD.                    SE DECISION MADE: 24-OCT-13
CINCINNATI OH 45242               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: BIPOLAR FORCEPS
BOSTON ENDO-SURGICAL TECHNOLOGIES,510(k) NO: K131058(TRADITIONAL)
ATTN: JAMES  ROGERS               PHONE NO : 203 336 7453   
1146 BARNUM AVENUE                SE DECISION MADE: 25-OCT-13
BRIDGEPORT CT 06610               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: PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K122783(TRADITIONAL)
ATTN: JULIE  TOM WING             PHONE NO : 610 984 9147   
3773 CORPORATE PARKWAY            SE DECISION MADE: 30-OCT-13
CENTER VALLEY PA 18034            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: U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K131116(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 3 5773351
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 30-OCT-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133122(ABBREVIATED)
ATTN: SUSAN  BROCCHI              PHONE NO : 914 524 2525   
511 BENEDICT AVE.                 SE DECISION MADE: 30-OCT-13
TARRYTOWN NY 10591                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

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

DEVICE: STENTBOOST REL. 4
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K132305(ABBREVIATED)
ATTN: LISELOTTE  KORNMANN         PHONE NO : 316 11 621238
VEENPLUIS 4-6                     SE DECISION MADE: 30-OCT-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
MAQUET CARDIOPULMONARY AG         510(k) NO: K132166(SPECIAL)
ATTN: INGRID  RICHTER             PHONE NO : 49 747892 10
KEHLER STRASSE 31                 SE DECISION MADE: 30-OCT-13
RASTATT    GM 76437               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX UNIVERS II CA HEADS
ARTHREX, INC.                     510(k) NO: K130675(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 30-OCT-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEOFUSE DENTAL IMPLANT SYSTEM
OSSEOFUSE, INC.                   510(k) NO: K131748(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST, UNIT B          SE DECISION MADE: 31-OCT-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS E.MAX CAD ABUTMENT SOLUTIONS
IVOCLAR VIVADENT AG               510(k) NO: K132209(ABBREVIATED)
ATTN: DONNA  HARTNETT             PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 31-OCT-13
AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUNA DENTAL IMPLANT SYSTEM
SHINHUNG MST CO., LTD             510(k) NO: K123155(ABBREVIATED)
ATTN: SUNBYUNG  LEE               PHONE NO : 823 373 01900
1642-8, DONGHWA-RI, MUNMAK-EUP    SE DECISION MADE: 31-OCT-13
WONJU-SI    KS 220-878            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMPCARE ESP THERAPY SYSTEM
AMPCARE, LLC                      510(k) NO: K131222(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 31-OCT-13
RICHARDSON TX 75080               510(k) STATEMENT

DEVICE: INVOTEC LARYNGEAL ELECTRODE
INVOTEC INTERNATIONAL, INC.       510(k) NO: K122040(TRADITIONAL)
ATTN: JEFFREY L AULL              PHONE NO : 904 880 1229   
6833 PHILLIPS INDUSTRIAL BLVD.    SE DECISION MADE: 31-OCT-13
JACKSONVILLE FL 32256 3029        510(k) STATEMENT

DEVICE: FIRMAP CATHETER
TOPERA, INC.                      510(k) NO: K130827(TRADITIONAL)
ATTN: MELISSA  WALKER             PHONE NO : 636 405 7498   
3668 S. GEYER ROAD SUITE 365      SE DECISION MADE: 31-OCT-13
ST. LOUIS MO 63127                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OFFROAD RE-ENTRY CATHETER SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K131914(TRADITIONAL)
ATTN: CAROL  TIFFANY              PHONE NO : 763 494 1106   
ONE SCIMED PLACE                  SE DECISION MADE: 31-OCT-13
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
NIDEK CO., LTD.                   510(k) NO: K131894(SPECIAL)
ATTN: YONEJI  MIZUNO              PHONE NO : 815 33 678901
34-14 MAEHAMA, HIROISHI-CHO       SE DECISION MADE: 31-OCT-13
GAMAGORI, AICHI    JA 443-0038    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIQUE
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K132705(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
3100 HANSEN WAY                   SE DECISION MADE: 31-OCT-13
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAXERAPACS
PAXERAMED                         510(k) NO: K132586(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 940 440 9530   
2001 E. OAK SHORES DR.            SE DECISION MADE: 31-OCT-13
AUBREY TX 76227                   510(k) STATEMENT

DEVICE: DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
MEDTRONIC INC.                    510(k) NO: K132995(SPECIAL)
ATTN: CHELSEA  PIOSKE             PHONE NO : 763 514 9838   
7611 NORTHLAND DRIVE              SE DECISION MADE: 31-OCT-13
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSB GLOBAL SPINAL BALANCE SYSTEM
NUVASIVE, INC.                    510(k) NO: K132014(TRADITIONAL)
ATTN: OLGA  LEWIS                 PHONE NO : 858 320 5257   
7475 LUSK BLVD                    SE DECISION MADE: 31-OCT-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALTUS SPINE PEDICLE SCREW SYSTEM
ALTUS PARTNERS                    510(k) NO: K132280(TRADITIONAL)
ATTN: CLAUDIA  HILL               PHONE NO : 610 355 4156   
5129 W CHESTER PIKE               SE DECISION MADE: 31-OCT-13
NEWTOWN SQUARE PA 19073 0000      510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   278                                     
                                                 TOTAL WITH SUMMARIES        258                                     
                                                 TOTAL WITH STATEMENTS        20
                                      

Page Last Updated: 01/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.