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U.S. Department of Health and Human Services

Medical Devices

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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