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Medical Devices

September 2013 510(k) Clearances

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


DEVICE: PROSIGNA BREAST CANCER PROGNOSIS GENE SIGNATURE ASSAY
NANOSTRING TECHNOLOGIES           510(k) NO: K130010(TRADITIONAL)
ATTN: SYLVA  KRIZAN, PHD          PHONE NO : 206 378 6266   
530 Fairview Ave N Ste 2000       SE DECISION MADE: 06-SEP-13
Seattle WA 98109                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K121033(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 06-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON XL HCG
DIASORIN, INC.                    510(k) NO: K131037(TRADITIONAL)
ATTN: MARI  MEYER                 PHONE NO : 651 351 5635   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 06-SEP-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.                      510(k) NO: K131813(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 06-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTAG CYP2C19 KIT V3
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K131565(TRADITIONAL)
ATTN: RONALD  DUNN                PHONE NO : 608 203895 0
439 UNIVERSITY AVE.               SE DECISION MADE: 11-SEP-13
TORONTO, ONTARIO    CA M5G 1Y8    510(k) STATEMENT

DEVICE: VYSIS D7S486/CEP 7 FISH PROBE KIT
ABBOTT MOLECULAR, INC.            510(k) NO: K131508(TRADITIONAL)
ATTN: NANCY W BENGTSON            PHONE NO : 224 361 7087   
1300 EAST TOUHY AVENUE            SE DECISION MADE: 13-SEP-13
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
BIOMERIEUX, INC.                  510(k) NO: K132573(TRADITIONAL)
ATTN: NATHAN  HARDESTY            PHONE NO : 314 731 8666   
595 ANGLUM RD.                    SE DECISION MADE: 13-SEP-13
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K122143(TRADITIONAL)
ATTN: ERIKA B AMMIRATI            PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 19-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
BIO-RAD LABORATORIES, INC.        510(k) NO: K130053(TRADITIONAL)
ATTN: JUANG  WANG                 PHONE NO : 510 741 4609   
5500 EAST 2ND ST.                 SE DECISION MADE: 19-SEP-13
BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS HERCEPTEST DIGITAL SCORE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130021(TRADITIONAL)
ATTN: DIRK  VOSSEN                PHONE NO : 316 511 81374
VEENPLUIS 4-6                     SE DECISION MADE: 19-SEP-13
BEST, NB    NL 5684 PC            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K132508(TRADITIONAL)
ATTN: HYE-JOO  KIM, PHARM.D.      PHONE NO : 404 639 4643   
1600 CLIFTON RD., N.E. MAILSTOP C-SE DECISION MADE: 23-SEP-13
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K121516(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 26-SEP-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K130275(TRADITIONAL)
ATTN: ROGER  DE BOCK              PHONE NO : 619 453 0930   
4455 MURPHY CANYON RD SUITE 204   SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE  URINE TEST  (MET 300)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K132630(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 27-SEP-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARILIFT-L INTERBODY FUSION DEVICE
WENZEL SPINE, INC.                510(k) NO: K131296(TRADITIONAL)
ATTN: SANDIE  ROTH                PHONE NO : 512 501 4022   
206 WILD BASIN RD, BLDG A, STE 203SE DECISION MADE: 03-SEP-13
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARDIS INTERBODY SYSTEM
ZIMMER SPINE, INC                 510(k) NO: K131242(TRADITIONAL)
ATTN: JON  GILBERT                PHONE NO : 952 830 6385   
                                  SE DECISION MADE: 03-SEP-13
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
BIOMET MANUFACTURING CORP.        510(k) NO: K123907(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 03-SEP-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESURFX 1565NM LASER MODULE
LUMENIS, LTD.                     510(k) NO: K130028(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4638 8837
31 HAAVODA ST.                    SE DECISION MADE: 03-SEP-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-MOTION II PS+ CUP
UNITED ORTHOPEDIC CORP.           510(k) NO: K132455(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2217
NO 57, PARK AVE. 2, SCIENCE PARK  SE DECISION MADE: 03-SEP-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC.      510(k) NO: K131540(TRADITIONAL)
ATTN: SURESH  GHAI                PHONE NO : 952 979 9357   
5909 BAKER ROAD SUITE 550         SE DECISION MADE: 03-SEP-13
MINNETONKA MN 55345               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
ACCEL SPINE                       510(k) NO: K132366(SPECIAL)
ATTN: AEKTA  PATEL                PHONE NO : 214 545 5833   
14901 QUORUM DR. STE. 125         SE DECISION MADE: 03-SEP-13
DALLAS TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
ACCESS SCIENTIFIC, LLC            510(k) NO: K131148(TRADITIONAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 04-SEP-13
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
DIACOUSTIC MEDICAL DEVICES (PTY) L510(k) NO: K131044(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 04-SEP-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSPACE
BIOSPACE CORPORATION LIMITED      510(k) NO: K131064(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 04-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA INTERSPINOUS PROCESS SYSTEM
SEASPINE, INC.                    510(k) NO: K121924(TRADITIONAL)
ATTN: NICK M CORDARO              PHONE NO : 760 216 5603   
2302 la Mirada Dr                 SE DECISION MADE: 04-SEP-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K131615(TRADITIONAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300   
399 JEFFERSON ROAD                SE DECISION MADE: 04-SEP-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
GE HUNGARY KFT                    510(k) NO: K132045(TRADITIONAL)
ATTN: STEPHEN  SLAVENS            PHONE NO : 262 548 4992   
3000 N GRANDVIEW DIVISION: DBA GE SE DECISION MADE: 04-SEP-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K131980(TRADITIONAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 952 830 6385   
7375 BUSH LAKE RD.                SE DECISION MADE: 04-SEP-13
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MP GRAYSCALE LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K132610(TRADITIONAL)
ATTN: WU  QIN                     PHONE NO : 86 755 26995355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 04-SEP-13
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KOSTEC MEDICAL GRADE LDC MONITORS
KOSTEC  CO., LTD                  510(k) NO: K123944(TRADITIONAL)
ATTN: RHONDA  ALEXANDER, MS, MPA  PHONE NO : 757 224 0177   
144 RESEARCH DRIVE MEDICAL DEVICE SE DECISION MADE: 05-SEP-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STITCHKIT
ORIGAMI SURGICAL LLC              510(k) NO: K123811(TRADITIONAL)
ATTN: JOHN  GILLESPIE             PHONE NO : 774 567 0277   
79 HAVEN ST.                      SE DECISION MADE: 05-SEP-13
DOVER MA 02030                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
SYNTHES                           510(k) NO: K123723(TRADITIONAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   
1301 GOSHEN PARKWAY               SE DECISION MADE: 05-SEP-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIX FOOT SYSTEM
JEIL MEDICAL CORPORATION          510(k) NO: K131311(TRADITIONAL)
ATTN: JI-EUN  KIM                 PHONE NO : 82 2 8503500
#702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 05-SEP-13
SEOUL-CITY    KS 152-050          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED WRIST SPANNING PLATE
ACUMED LLC                        510(k) NO: K131764(TRADITIONAL)
ATTN: NATHAN  WOLF                PHONE NO : 503 207 1502   
5885 NW Cornelius Pass Rd         SE DECISION MADE: 05-SEP-13
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
ST. JUDE MEDICAL SYSTEMS AB       510(k) NO: K131452(TRADITIONAL)
ATTN: ERDULFO  DE PERALTA         PHONE NO : 978 577 3481   
4 ROBBINS RD.                     SE DECISION MADE: 05-SEP-13
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z5MLB, Z5MLC
Z-SYSTEMS AG                      510(k) NO: K131701(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
12264 EL CAMINO REAL STE. 400     SE DECISION MADE: 05-SEP-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEPHAFLEX BRAIDED SUTURE
TEPHA, INC.                       510(k) NO: K132348(TRADITIONAL)
ATTN: MARY P LEGRAW               PHONE NO : 781 357 1709   
99 HAYDEN, SUTIE 360              SE DECISION MADE: 05-SEP-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON 25 TOTAL-D
DIASORIN, INC.                    510(k) NO: K132492(TRADITIONAL)
ATTN: MARI  MEYER                 PHONE NO : 651 351 5635   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 05-SEP-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
TELEFLEX MEDICAL, INC.            510(k) NO: K122235(SPECIAL)
ATTN: LORI  PFOHL                 PHONE NO : 919 433 4908   
2917 WECK DR.                     SE DECISION MADE: 06-SEP-13
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEMIE BREAST COLLECTION SYSTEM
DAO HEALTH                        510(k) NO: K130349(TRADITIONAL)
ATTN: DAN  GARBEZ                 PHONE NO : 916 339 7388   
1345 EASY LN. EL DORADO HILLS     SE DECISION MADE: 06-SEP-13
CALIFORNIA CA 95762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUSHA-C31 MEDICAL DISPLAY
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131389(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 20 62321333
7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERCT REL. 3
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130893(ABBREVIATED)
ATTN: LISELOTTE  KORNMANN         PHONE NO : 31 611621 238
VEENPLUIS 4-6                     SE DECISION MADE: 06-SEP-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEAK Z
ULTRADENT PRODUCTS, INC.          510(k) NO: K131357(TRADITIONAL)
ATTN: DIANE  ROGERS               PHONE NO : 801 553 4491   
505 WEST 10200 SOUTH              SE DECISION MADE: 06-SEP-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
WORLDMED MANUFACTURING SDN. BHD.  510(k) NO: K121844(TRADITIONAL)
ATTN: CHANDRASEGARAN              PHONE NO : 605 829 5555
LOT 18873, JALAN PERUSAHAAN 3, KAMSE DECISION MADE: 06-SEP-13
KAMUNTING    MY 34600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIVECOR HEART MONITOR
ALIVECOR, INC.                    510(k) NO: K130409(TRADITIONAL)
ATTN: MICHAEL  RIGHTER            PHONE NO : 415 795 9812   
30 MAIDEN LANE, 6TH FLOOR         SE DECISION MADE: 06-SEP-13
SAN FRANCISCO CA 94108            510(k) STATEMENT

DEVICE: STRAWBERRY, STRAWBERRY & CREAM
LASER LIPO LIMITED                510(k) NO: K130341(TRADITIONAL)
ATTN: IAN  COBLEY                 PHONE NO : 011 44 8449801820
HEATH HOUSE, CROCKHAM HILL        SE DECISION MADE: 06-SEP-13
EDENBRIDGE, KENT    UK TN8 6ST    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE SEAMGUARD REINFORCEMENT
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K131658(TRADITIONAL)
ATTN: BARBARA L SMITH             PHONE NO : 410 506 8189   
301 AIRPORT RD.                   SE DECISION MADE: 06-SEP-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
MEDOS INTERNATIONAL SARL          510(k) NO: K132324(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 06-SEP-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-PACK II NEEDLE - 27G X 3/4" THIN WALL
TERUMO EUROPE N.V.                510(k) NO: K132233(SPECIAL)
ATTN: M.J.  AERTS                 PHONE NO : 320 163812 11
INTERLEUVENLAAN 40                SE DECISION MADE: 06-SEP-13
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPREHENSIVE REVERSE SHOULDER SCREWS
BIOMET MANUFACTURING CORP.        510(k) NO: K132239(TRADITIONAL)
ATTN: PATRICIA S BERES            PHONE NO : 574 267 6639   
56 BELL DRIVE                     SE DECISION MADE: 06-SEP-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRECR DENTALIMAGING SYSTEM
3DISC AMERICAS                    510(k) NO: K131442(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 06-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYESEECAM VHIT
INTERACOUSTICS A/S                510(k) NO: K131681(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 45 637 13555
DREJERVAENGET 8                   SE DECISION MADE: 06-SEP-13
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMAGE CPT SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K132431(SPECIAL)
ATTN: RAYMOND  LEE                PHONE NO : 510 259 7159   
25881 INDUSTRIAL BLVD.            SE DECISION MADE: 06-SEP-13
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE GROUNDING PAD
LCCS PRODUCTS LIMITED             510(k) NO: K132136(TRADITIONAL)
ATTN:                             PHONE NO : 
7TH FL, JINGGUI BUSINESS BLDG, NO.SE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS LIBERTY CYCLER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K123630(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER ST                     SE DECISION MADE: 09-SEP-13
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIRE PINK SERIES - HERBST
RESPIRE MEDICAL                   510(k) NO: K131138(TRADITIONAL)
ATTN: DANIELA  LEVY               PHONE NO : 213 787 3026   
22817 VENTURA BLVD #161           SE DECISION MADE: 09-SEP-13
WOODLAND HILLS CA 91364           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
BAUSCH & LOMB INCORPORATED        510(k) NO: K132216(SPECIAL)
ATTN: SAMANTHA  DUFFY             PHONE NO : 585 338 8187   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 09-SEP-13
ROCHESTER NY 14609                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSIGN FLU A + B, STATUS FLU A & B
PRINCETON BIOMEDITECH CORP.       510(k) NO: K132465(SPECIAL)
ATTN: KYUNG-AH  KIM, PH.D.        PHONE NO : 732 274 1000   
4242 U.S. RT. 1                   SE DECISION MADE: 09-SEP-13
MONMOUTH JUNCTION NJ 08852 1905   510(k) STATEMENT

DEVICE: POWER FREE VINYL EXAMINATION GLOVES
WANG TONG XINGHUA CO., LTD        510(k) NO: K122102(TRADITIONAL)
ATTN: GUO  YANG                   PHONE NO : 865 238 3495629
WEST OF GUO JING ROAD ECONOMIC DEVSE DECISION MADE: 09-SEP-13
XINGHUA    CH 225700              510(k) STATEMENT

DEVICE: EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
ST. JUDE MEDICAL                  510(k) NO: K132073(SPECIAL)
ATTN: KRIS  MILLER                PHONE NO : 651 756 2954   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 09-SEP-13
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX UNIVERSAL ADHESIVE
APEX DENTAL MATERIALS, INC.       510(k) NO: K131043(TRADITIONAL)
ATTN: CHRIS  KULTON               PHONE NO : 847 719 1133   
330 TELSER ROAD                   SE DECISION MADE: 10-SEP-13
LAKE ZURICH IL 60047              510(k) STATEMENT

DEVICE: CCS-200 SPIROMETER
BENSON MEDICAL INSTRUMENTS CO.    510(k) NO: K123896(TRADITIONAL)
ATTN: DAVID  MAYOU                PHONE NO : 612 827 2222   
310FOURTH AVE SOUTH SUITE 5000    SE DECISION MADE: 10-SEP-13
MINNEAPOLIS MN 55415              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
CHURCH & DWIGHT CO., INC.         510(k) NO: K123567(TRADITIONAL)
ATTN: LISA  BURNS                 PHONE NO : 609 497 7482   
469 NORTH HARRISON STREET         SE DECISION MADE: 10-SEP-13
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SPINE SYSTEM
CORELINK LLC                      510(k) NO: K131250(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE              SE DECISION MADE: 10-SEP-13
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETROGRADE FEMORAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K132005(TRADITIONAL)
ATTN: ALLYSON  PARKS              PHONE NO : 310 533 9966   
386 Beech Ave. Unit B6            SE DECISION MADE: 10-SEP-13
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
BAUSCH & LOMB, INC.               510(k) NO: K131208(TRADITIONAL)
ATTN: BARBARA  KLUBE-FALSO        PHONE NO : 585 338 8503   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 11-SEP-13
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IHEALTH FINGERTIP PULSE OXIMETER
ANDON HEALTH CO.,LTD              510(k) NO: K131111(TRADITIONAL)
ATTN: LIU  YU                     PHONE NO : 86 22 60526161
#3,  JIN PING STREET YA AN RD NANKSE DECISION MADE: 11-SEP-13
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHOFU BLOCK HC
SHOFU DENTAL CORPORATION          510(k) NO: K130841(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DRIVE                  SE DECISION MADE: 11-SEP-13
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC.               510(k) NO: K131021(TRADITIONAL)
ATTN: BRODIE  PEDERSEN            PHONE NO : 763 577 3180   
13700 1ST AVE. NORTH              SE DECISION MADE: 11-SEP-13
PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KITAZATO IUI CATHETER
KITAZATO MEDICAL CO., LTD.        510(k) NO: K131491(TRADITIONAL)
ATTN: RICHARD  VINCINS, CBA, CQA, PHONE NO : 512 327 9997   
816 CONGRESS AVE. STE. 1400       SE DECISION MADE: 11-SEP-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL GOWN (EO STERILIZED)
COBES INDUSTRIES CO., LTD.        510(k) NO: K112796(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 12-SEP-13
DOVER DE 19901                    510(k) STATEMENT

DEVICE: AUTOMATIC BLOOD PRESSURE MONITOR
HONSUN (NANTONG) CO., LTD.        510(k) NO: K130925(TRADITIONAL)
ATTN: SELINA  QIAN                PHONE NO : 86 0513 80580022
NO.8, Tongxing Road, Nantong EconoSE DECISION MADE: 12-SEP-13
NANTONG, JIANGSU    CH 226009     510(k) STATEMENT

DEVICE: JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
JUNG RIM MEDICAL INDUSTRIAL CO., L510(k) NO: K124037(TRADITIONAL)
ATTN: KYU  LEE                    PHONE NO : 82 2 4047986
#593-81, SAGOK-RI, LWOL-MYEON     SE DECISION MADE: 12-SEP-13
JINCHEON-GUN, CHUNGBUK    KN 365-8510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
AUDIFON-USA INC.                  510(k) NO: K130417(ABBREVIATED)
ATTN: JANE E PERRONE              PHONE NO : 386 668 8812   
403 CHAIRMAN CT., STE. 1          SE DECISION MADE: 12-SEP-13
DEBARY FL 32713                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPROPHY MOBILE
NAKANISHI, INC.                   510(k) NO: K131578(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 12-SEP-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL PASTE STAINS AND GLAZE
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K130604(TRADITIONAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 225 1234   
2212 DUPONT DR., SUITE JJK        SE DECISION MADE: 12-SEP-13
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVORTE BVF
VIVORTE, INC                      510(k) NO: K130703(TRADITIONAL)
ATTN: STEPHEN J PEOPLES           PHONE NO : 260 645 0327   
5010 LODGE PLE LANE               SE DECISION MADE: 12-SEP-13
FORT WAYNE IN 46814               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QXLINK
VIEWORKS CO., LTD.                510(k) NO: K132302(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E. KATELLA AVENUE UNIT 2115  SE DECISION MADE: 12-SEP-13
ANAHEIM CA 92805                  510(k) STATEMENT

DEVICE: EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K131802(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 12-SEP-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTISTIM
METRON MEDICAL AUSTRALIA PTY LTD  510(k) NO: K132137(SPECIAL)
ATTN: DAVID  MITCHELL             PHONE NO : 613 977 51234
57 ASTER AVE.                     SE DECISION MADE: 12-SEP-13
CARRUM DOWNS, VICTORIA    AS 3201 510(k) STATEMENT

DEVICE: ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
CEREMED, INC.                     510(k) NO: K132198(TRADITIONAL)
ATTN: CHELSEA  MITCHELL           PHONE NO : 310 815 2125   
3643 LENAWEE AVE.                 SE DECISION MADE: 12-SEP-13
LOS ANGELES CA 90016              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCULIF TL AND PL CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K132505(SPECIAL)
ATTN:                             PHONE NO : 
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 12-SEP-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAS PSI KNEE SYSTEM
ORTHOSOFT, INC.                   510(k) NO: K131409(TRADITIONAL)
ATTN: CHRISTOPHER  MCLEAN         PHONE NO : 514 861 4074   
75 QUEEN ST., SUITE 3300          SE DECISION MADE: 13-SEP-13
MONTREAL, QUEBEC    CA H3C 2N6    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
INTUITIVE SURGICAL, INC.          510(k) NO: K124031(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
1266 KIFER ROAD BUILDING 101      SE DECISION MADE: 13-SEP-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ELITE DIODE LASER
CAO GROUP, INC.                   510(k) NO: K131059(TRADITIONAL)
ATTN: ROBERT K LARSEN             PHONE NO : 801 256 9282   
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 13-SEP-13
WEST JORDAN UT 84084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K132175(TRADITIONAL)
ATTN: LUKE  MEIDELL               PHONE NO : 801 565 6212   
12050 LONE PEAK PKWY              SE DECISION MADE: 13-SEP-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
BINDER BIOMEDICAL, INC            510(k) NO: K130641(TRADITIONAL)
ATTN: LAWRENCE  BINDER            PHONE NO : 561 981 2682   
1951 NW 7TH AVENUE, STE 13135     SE DECISION MADE: 13-SEP-13
MIAMI FL 33136                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
OKTX LLC                          510(k) NO: K123902(TRADITIONAL)
ATTN: MARY ROSE C REASTON         PHONE NO : 702 234 1014   
7225 S 85TH E AVE. SUITE 300      SE DECISION MADE: 13-SEP-13
TULSA OK 74137                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOBSTER AUTO-INJECTOR
SCANDINAVIAN HEALTH LIMITED       510(k) NO: K124026(TRADITIONAL)
ATTN: JAMES  HAYNES               PHONE NO : 954 725 2046   
#588 JIM MORAN BLVD               SE DECISION MADE: 13-SEP-13
DEERFIELD BEACH FL 33442          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SASMAR ORIGINAL, SASMAR CLASSIC
SASMAR INC                        510(k) NO: K131084(TRADITIONAL)
ATTN: JOHN-MICHAEL  MANCINI       PHONE NO : 773 942 0030   
155 NORTH WACKER DR, STE 4250     SE DECISION MADE: 13-SEP-13
CHICAGO IL 60606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
VITAL ACCESS                      510(k) NO: K130873(TRADITIONAL)
ATTN: CHRISTOPHER  PHILLIPS       PHONE NO : 801 433 9390   
2302 S.PRESIDENTS DR SUITE C      SE DECISION MADE: 13-SEP-13
SALT LAKE CITY UT 84120           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANYX
MEDECELL US, INC                  510(k) NO: K123866(TRADITIONAL)
ATTN: RHONDA  ALEXANDER, M.S., M.PPHONE NO : 757 224 0177   
144 RESEARCH DRIVE                SE DECISION MADE: 13-SEP-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K132578(SPECIAL)
ATTN: TODD  KORNMANN              PHONE NO : 763 494 1348   
ONE SCIMED PLACE                  SE DECISION MADE: 13-SEP-13
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEROX
OR-NIM MEDICAL LTD.               510(k) NO: K131854(SPECIAL)
ATTN: MICHA  OESTEREICH           PHONE NO : 972 892 82801
15 ATIR YEDA ST.                  SE DECISION MADE: 13-SEP-13
KFAR SABA    IS 4464312           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR FT4, ADVIA CENTAUR T4
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K132249(TRADITIONAL)
ATTN: MATTEW  GEE                 PHONE NO : 914 524 2099   
511 BENEDICT AVE.                 SE DECISION MADE: 13-SEP-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROSURGICAL GENERATOR
BEIJING JINHENGWEI TECHNOLOGY DEVE510(k) NO: K130760(TRADITIONAL)
ATTN: LIGANG  MAO                 PHONE NO : 86 10 67916414
NO. 631 XINGONG VILLAGE EAST SIDE SE DECISION MADE: 16-SEP-13
BEIJING    CH 100069              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ERCHONIA EMERGE
ERCHONIA MEDICAL, INC.            510(k) NO: K130996(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 16-SEP-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: PNEUPAC PARAPAC PLUS
SMITHS MEDICAL INTERNATIONAL LTD. 510(k) NO: K123957(TRADITIONAL)
ATTN: LORI  BERENDS               PHONE NO : 
BRAMINGHAM BUSINESS PARK ENTERPRISSE DECISION MADE: 16-SEP-13
LUTON, BEDFORDSHIRE    UK LU3 4BU 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY CORAIL AMT HIP PROSTHESIS
DEPUY FRANCE S.A.S.               510(k) NO: K123991(TRADITIONAL)
ATTN: ALMA  RELJA, RAC            PHONE NO : 574 372 7349   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 16-SEP-13
WARSAW IN 46581                   510(k) STATEMENT

DEVICE: NOVOKNEE TOTAL KNEE SYSTEM
NOVOSOURCE INC                    510(k) NO: K131398(TRADITIONAL)
ATTN: JAMES  PINKSTON             PHONE NO : 435 774 1502   
560 W. GOLF COURSE RD CO-INNOVATIOSE DECISION MADE: 16-SEP-13
PROVIDENCE UT 84332               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K130802(TRADITIONAL)
ATTN: JIANPING  KANG              PHONE NO : 86 755276 52471
XILIXIAOBAIMANG                   SE DECISION MADE: 16-SEP-13
SHENZHEN, GUANGDONG    CH 518108  510(k) STATEMENT

DEVICE: RAMPART-O, RAMPART-T
SPINEOLOGY, INC.                  510(k) NO: K132053(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8534   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 16-SEP-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEART SYNC
HEART SYNC INC.                   510(k) NO: K131494(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 16-SEP-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
HELIX MEDICAL, LLC                510(k) NO: K131745(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
1110 MARK AVE.                    SE DECISION MADE: 17-SEP-13
CARPINTERIA CA 93013              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CREODENT SOLIDEX CUSTOM ABUTMENT
CREODENT PROSTHETICS LTD.         510(k) NO: K113738(TRADITIONAL)
ATTN: CALVIN  SHIM                PHONE NO : 212 302 3860   
29TH WEST STREET 11TH FLOOR       SE DECISION MADE: 17-SEP-13
NEW YORK NY 10001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACIAL SPA
NUSKIN                            510(k) NO: K122711(TRADITIONAL)
ATTN: PAUL  RUBIN                 PHONE NO : 202 508 4709   
ONE METRO CENTER 700 12TH STREET, SE DECISION MADE: 17-SEP-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR
RAYENCE CO., LTD                  510(k) NO: K131114(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 17-SEP-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K131161(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
102 FIRST ST. SOUTH               SE DECISION MADE: 17-SEP-13
Kalona IA 52247                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
JINXINBAO ELECTRONIC CO.,LTD      510(k) NO: K130232(ABBREVIATED)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182
ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 17-SEP-13
WENZHOU, ZHEJIANG    CH 325000    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANSWATCH WRIST MONITOR MODEL TS-0411
TAIWAN SCIENTIFIC CORPORATION     510(k) NO: K123130(TRADITIONAL)
ATTN: DEHCHUAN  SUN               PHONE NO : 886 2 86673362
10F, 88-4, MING-CHIUAN RD, SHIN-DISE DECISION MADE: 17-SEP-13
NEW TAIPEI    TW 23141            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
ZIMMER, INC.                      510(k) NO: K130595(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 17-SEP-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VCARE A
IVT MEDICAL LTD                   510(k) NO: K121817(TRADITIONAL)
ATTN: ELI  ORBACH                 PHONE NO : 972 299 32768
POB 6718                          SE DECISION MADE: 17-SEP-13
EFRAT    IS 91435                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K132591(SPECIAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 17-SEP-13
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYSTALSERT DELIVERY SYSTEM
BAUSCH & LOMB                     510(k) NO: K132593(SPECIAL)
ATTN: YI  GAO                     PHONE NO : 949 521 7933   
30 ENTERPRISE, SUITE 450          SE DECISION MADE: 17-SEP-13
ALISO VIEJO CA 92656 7115         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
EDAN INSTRUMENTS, INC.            510(k) NO: K131830(TRADITIONAL)
ATTN: CHERRY  SUN                 PHONE NO : 867 55 26856469
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 17-SEP-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
GE HEALTHCARE                     510(k) NO: K131977(TRADITIONAL)
ATTN: NICOLE  LANDREVILLE         PHONE NO : 289 208 2365   
540 W. NORTHWEST HIGHWAY          SE DECISION MADE: 17-SEP-13
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
ARTHROCARE CORPORATION            510(k) NO: K132590(SPECIAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 West William Cannon Drive    SE DECISION MADE: 17-SEP-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABL90 FLEX ANALYZER
RADIOMETER MEDICAL APS            510(k) NO: K131988(TRADITIONAL)
ATTN: GITTE JUEL  FRIIS           PHONE NO : 453 82 73384
AKANDEVEJ 21                      SE DECISION MADE: 17-SEP-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSPAN STEERABLE INTRODUCER KIT
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K132164(SPECIAL)
ATTN: ALINA  STUBBS               PHONE NO : 610 651 5000   
65 GREAT VALLEY PAKRWAY           SE DECISION MADE: 17-SEP-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GC-3000E DIGITAL COLPOSCOPE
GOLDCARE MEDITECH CO., LTD        510(k) NO: K122311(TRADITIONAL)
ATTN: JIMMY  WU                   PHONE NO : 626 799 0989   
2600 MISSION STREET STE 100       SE DECISION MADE: 18-SEP-13
SAN MARINO CA 91108               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHA-PRO WHITE VARNISH
DENTAL TECHNOLOGIES, INC.         510(k) NO: K124025(TRADITIONAL)
ATTN: PAULA  ERICKSON             PHONE NO : 847 677 5500   
6901 NORTH HAMLIN AVE.            SE DECISION MADE: 18-SEP-13
Lincolnwood IL 60712              510(k) STATEMENT

DEVICE: TRANSTEK GLASS BODY FAT ANALYZER
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K131394(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 18-SEP-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTBUILDER SYSTEM (SB1)
OSSTEM IMPLANT CO.,LTD            510(k) NO: K130840(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR.               SE DECISION MADE: 18-SEP-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K131122(ABBREVIATED)
ATTN: SHARYN  ORTON, PH.D.        PHONE NO : 401 330 8264   
200 HOMER AVE                     SE DECISION MADE: 18-SEP-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIOS FLOW CYTOMETER SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K130373(TRADITIONAL)
ATTN: NANCY  NADLER               PHONE NO : 305 380 4191   
11800 SW 147 AVE                  SE DECISION MADE: 18-SEP-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE ANTI-REFLUX VALVE
MEDLINE INDUSTRIES, INC.          510(k) NO: K132314(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 18-SEP-13
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: APD LUER-LOCK ADAPTER
FRESENSIUS MEDICAL CARE NORTH AMER510(k) NO: K124024(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER ST                     SE DECISION MADE: 19-SEP-13
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOLAP SYSTEM
MST - MEDICAL SURGERY TECHNOLOGIES510(k) NO: K131375(TRADITIONAL)
ATTN: JOHN J SMITH, M.D., J.D.    PHONE NO : 202 637 3638   
555 THIRTEENTH STREET NW          SE DECISION MADE: 19-SEP-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
ZIMMER, INC.                      510(k) NO: K130810(TRADITIONAL)
ATTN: SCOTT M DURLACHER           PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD, STE 200       SE DECISION MADE: 19-SEP-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVIS BIPOLAR HIP SYSTEM
RENOVIS SURGICAL TECHNOLOGIES LLC 510(k) NO: K131354(TRADITIONAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264   
200 HOMER AVE                     SE DECISION MADE: 19-SEP-13
ASHLAND MA 0172 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
INTERVENTIONAL SPINE, INC.        510(k) NO: K132479(SPECIAL)
ATTN: JANE  METCALF               PHONE NO : 949 472 0006   
13700 ALTON PKWY., SUITE 160      SE DECISION MADE: 19-SEP-13
IRVINE CA 92618                   510(k) STATEMENT

DEVICE: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
PIPELINE BIOTECHNOLOGY            510(k) NO: K132626(SPECIAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
575 EIGHTH AVE, SUITE 1212        SE DECISION MADE: 19-SEP-13
NEW YORK NY 10018                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUINOX CO2 LASER
ECLIPSE AESTHETICS, LLC           510(k) NO: K131903(SPECIAL)
ATTN: TOM  O'BRIEN                PHONE NO : 972 380 2911   
13988 Diplomat Dr Suite 160       SE DECISION MADE: 19-SEP-13
Dallas TX 75234                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
TORNIER, INC.                     510(k) NO: K132632(SPECIAL)
ATTN: JANELL A COLLEY             PHONE NO : 952 426 7600   
10801 NESBITT AVENUE SOUTH        SE DECISION MADE: 19-SEP-13
BLOOMINGTON MN 55437              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
ARTHROCARE CORPORATION            510(k) NO: K132513(SPECIAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 19-SEP-13
AUSTIN TX 78735 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
CORENTEC CO., LTD                 510(k) NO: K132644(SPECIAL)
ATTN: J.S.  DANIEL                PHONE NO : 827 04 3933819
8TH FLOOR CHUNGHO TOWER 748-1 BANPSE DECISION MADE: 19-SEP-13
SEOCHO GU, SEOUL    KN 137-040    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER
REFLOW MEDICAL                    510(k) NO: K132420(SPECIAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1003 Calle Sombra                 SE DECISION MADE: 19-SEP-13
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINUFLUSH LAVAGE SYSTEM
HEDGEPATH, LLC                    510(k) NO: K131177(TRADITIONAL)
ATTN: FRANK E O'DONNELL, JR MD.   PHONE NO : 314 258 6446   
324 S. HYDE PARK AVE. SUITE 350   SE DECISION MADE: 20-SEP-13
TAMPA FL 33606                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MROZ REVERSE OSMOSIS SYSTEM
AMERIWATER                        510(k) NO: K131622(TRADITIONAL)
ATTN: BRIAN R BOWMAN              PHONE NO : 937 461 8833   
1303 STANLEY AVE.                 SE DECISION MADE: 20-SEP-13
DAYTON OH 45404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K132391(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVENUE               SE DECISION MADE: 20-SEP-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM (MCS), VFC
MICROVENTION, INC.                510(k) NO: K132317(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 20-SEP-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM IA AND IA PLUS
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K132091(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959   
325 BIG ELM ST.                   SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROENT SINGLE TAB SYSTEM
NUVASIVE, INC.                    510(k) NO: K131723(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309 3783   
7475 LUSK BLVD                    SE DECISION MADE: 20-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
LEXION MEDICAL, LLC.              510(k) NO: K132203(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 20-SEP-13
VADNAIS HEIGHTS MN 55127          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM WBT
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K132174(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959   
325 BIG ELM ST.                   SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE CERVICAL IBF SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K131429(TRADITIONAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280   
P.O. BOX 1693                     SE DECISION MADE: 23-SEP-13
BOUNTIFUL UT 84011                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
ENCORE MEDICAL, L.P.              510(k) NO: K130365(TRADITIONAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 832 9500   
9800 METRIC BLVD.                 SE DECISION MADE: 23-SEP-13
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELIMED STEAM STERILIZER MST-V
BELIMED, INC.                     510(k) NO: K130172(ABBREVIATED)
ATTN: JAY  UPCHURCH               PHONE NO : 843 216 7424   
2284 Clements Ferry Road          SE DECISION MADE: 23-SEP-13
Charleston SC 29492               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130177(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIPELINE KNEE SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K132046(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 101        SE DECISION MADE: 23-SEP-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
DORNIER MEDTECH AMERICA           510(k) NO: K132672(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 23-SEP-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K131888(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI-BAR
CENDRES & METAUX SA               510(k) NO: K131526(TRADITIONAL)
ATTN: TANJA  BONGNI               PHONE NO : 415 836023 02
RUE DE BOUJEAN 122                SE DECISION MADE: 23-SEP-13
BIEL/BIENNE    SZ 2501            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: K132692(SPECIAL)
ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 23-SEP-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DESARA MESH, DESARA BLUE
CALDERA MEDICAL, INC.             510(k) NO: K132069(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 483 7602   
5171 CLARETON DRIVE               SE DECISION MADE: 23-SEP-13
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOCAM
KALTENBACH & VOIGT GMBH           510(k) NO: K123402(TRADITIONAL)
ATTN: STEFAN  TRAMPLER            PHONE NO : 49 735 10563515
BISMARCHRING 39                   SE DECISION MADE: 24-SEP-13
BIBERACH / RISS    GM 88400       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYSTAL ULTRA
DENTAL LABORATORY MILLING SUPPLIES510(k) NO:  K130654(TRADITIONAL)
ATTN: SCOTT  ATKIN                PHONE NO : 480 948 0466   
14201 N 87TH ST #A101             SE DECISION MADE: 24-SEP-13
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE ECHOPAC
GE VINGMED ULTRASOUND AS          510(k) NO: K131685(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 47 330212 80
STRANDPROMENADEN 45 PO BOX 141    SE DECISION MADE: 24-SEP-13
HORTEN    NO N-3191               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON I/E
GE HEALTHCARE                     510(k) NO: K131937(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 24-SEP-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIXPLORER
SUPERSONIC IMAGINE                510(k) NO: K132274(SPECIAL)
ATTN: JACQUES  SONQUET            PHONE NO : 334 42 992424
510 RUE RENE DESCARTES            SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE  CEDEX    FR 13857510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIXPLORER
SUPERSONIC IMAGINE                510(k) NO: K132171(TRADITIONAL)
ATTN: AURELIE  GRUENER            PHONE NO : 33 442 992424
510 RUE RENE DESCARTES            SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE    FR 13857       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRILLIANCE ICT
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K131773(SPECIAL)
ATTN: CATHERINE M CONNELL         PHONE NO : 440 483 5581   
595 MINER RD.                     SE DECISION MADE: 24-SEP-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHENGGUANG MANUAL WHEELCHAIR
PINGDINGSHAN SHENXING HEALTHCARE T510(k) NO: K131529(TRADITIONAL)
ATTN: WANG  QING                  PHONE NO : 
XINXING RD. SOUTH OF INDUSTRIAL PASE DECISION MADE: 24-SEP-13
PINGDINGSHAN CITY, HENAN    CH    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
DENTALEZ GROUP, STARDENTAL DIVISIO510(k) NO: K130455(TRADITIONAL)
ATTN: JIM  WATKINS                PHONE NO : 717 291 1161   
1816 COLONIAL VILLAGE LN.         SE DECISION MADE: 25-SEP-13
LANCASTER PA 17601                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-GEN
MEGAGEN IMPLANT CO., LTD          510(k) NO: K131289(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 25-SEP-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX COMPRESSION PLATES
ARTHREX, INC.                     510(k) NO: K130510(TRADITIONAL)
ATTN: IVETTE  GALMEZ              PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 25-SEP-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
METHODSENSE, INC.                 510(k) NO: K131873(TRADITIONAL)
ATTN: RITA  KING                  PHONE NO : 919 313 3960   
P.O. BOX 110352                   SE DECISION MADE: 25-SEP-13
DURHAM NC 27709                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XVI R5.0
ELEKTA LIMITED                    510(k) NO: K131965(TRADITIONAL)
ATTN: ANDREW  HEDGES              PHONE NO : 441 293654 201
LINAC HOUSE, FLEMING WAY          SE DECISION MADE: 25-SEP-13
CRAWLEY, WEST SUSSEX    UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K131891(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
911 HANSEN WAY                    SE DECISION MADE: 25-SEP-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
LUCENXIA PRESCIENCE AG            510(k) NO: K131751(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 41 417689 126
RATHAUSSTRASSE 7                  SE DECISION MADE: 25-SEP-13
BAAR, ZUG    SZ 6341              510(k) STATEMENT

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K131440(TRADITIONAL)
ATTN: CHARLES  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 25-SEP-13
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K121790(TRADITIONAL)
ATTN: KERRIE  OETTER              PHONE NO : 952 368 7858   
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 25-SEP-13
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JAZZ SYSTEM
HOGAN LOVELLS US LLP              510(k) NO: K132287(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST 29TH FL            SE DECISION MADE: 25-SEP-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICHEM P
TECHNO-PATH MANUFACTURING LTD.    510(k) NO: K131992(ABBREVIATED)
ATTN: STEPHANIE G GARTH           PHONE NO : 469 230 0959   
325 BIG ELM ST.                   SE DECISION MADE: 25-SEP-13
HIGHLAND VILLAGE TX 75077         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
BAYER HEALTHCARE                  510(k) NO: K122370(TRADITIONAL)
ATTN: ROGER  SONNENBURG           PHONE NO : 574 256 3441   
430 SOUTH BEIGER STREET           SE DECISION MADE: 26-SEP-13
MISHAWAKA IN 46544                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
LIGHTMED CORP.                    510(k) NO: K124043(TRADITIONAL)
ATTN: JOCELYN  LIU                PHONE NO : 886 22688 1726
NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 26-SEP-13
NEW TAIPEI CITY    TW 23861       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COSEAL
JILIN CORONADO MEDICAL LTD.       510(k) NO: K131411(TRADITIONAL)
ATTN: ERIC  CHIEN                 PHONE NO : 86 432635 29555
9 South-Western Circle Road FenmanSE DECISION MADE: 26-SEP-13
Jilin    CH 132016                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRO CT SYSTEM
MOBIUS IMAGING, LLC               510(k) NO: K131431(TRADITIONAL)
ATTN: NORMA  LEMAY                PHONE NO : 978 391 9644   
323 WEST MAIN STREET              SE DECISION MADE: 26-SEP-13
AYER MA 01432                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISION ONE LIFECARE; DETECTO; DETECTO
PRECISION ONE LIFECARE, LTD.      510(k) NO: K130952(TRADITIONAL)
ATTN: STEVEN  CHERNOFF            PHONE NO : 425 861 8262   
PO BOX 3515                       SE DECISION MADE: 26-SEP-13
REDMOND WA 98073                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENII ARC SMART ARGON PROBE
GENII, INC.                       510(k) NO: K130983(TRADITIONAL)
ATTN: TRACY  EBERLY               PHONE NO : 612 716 1209   
3640 PILLSBURY AVE                SE DECISION MADE: 26-SEP-13
MINNEAPOLIS MN 55409              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSCEND HEATED HUMIDIFIER
SOMNETICS INTERNATIONAL, INC.     510(k) NO: K131388(TRADITIONAL)
ATTN: MELINDA  SWANSON            PHONE NO : 651 621 1800   
33 5TH AVE NW, STE 500            SE DECISION MADE: 26-SEP-13
NEW BRIGHTON MN 55112             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K132700(SPECIAL)
ATTN: ANKIT K SHAH                PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 26-SEP-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132654(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 650 694 5658   
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 26-SEP-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TCM MASSAGER
ANHUI JINJIANQIAO MED-TECH CO,. LT510(k) NO: K130150(TRADITIONAL)
ATTN: FIELD  FU                   PHONE NO : 86 755 86069197
05C.FUHAI KANGLE BUILDING NANSHAN SE DECISION MADE: 26-SEP-13
SHENZHEN, GUANGDONG    CH 518000  510(k) STATEMENT

DEVICE: PRIMI SUPPORT CATHETER
THERMOPEUTIX INC.                 510(k) NO: K132701(SPECIAL)
ATTN: JASON  FORD                 PHONE NO : 858 549 1760   
9951B BUSINESSPARK AVE            SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92131                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
GE MEDICAL SYSTEMS SCS            510(k) NO: K131885(TRADITIONAL)
ATTN: MOUNIR  ZAOUALI             PHONE NO : 33 130 704539
283 RUE DE LA MINIERE             SE DECISION MADE: 26-SEP-13
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOCROSS ELITE .14" OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
EV3 INC                           510(k) NO: K132777(TRADITIONAL)
ATTN:                             PHONE NO : 
3033 CAMPUS DRIVE                 SE DECISION MADE: 26-SEP-13
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PROTURA COUCH SOFTWARE
MED-TEC, INC. D/B/A CIVCO MEDICAL 510(k) NO: K132084(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
1401 8TH STREET SE                SE DECISION MADE: 26-SEP-13
ORANGE CITY IA 51041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COCHLEAR BAHA  4 SOUND PROCESSOR
COCHLEAR AMERICAS                 510(k) NO: K132278(SPECIAL)
ATTN: SEAN  BUNDY                 PHONE NO : 303 790 9010   
13059 EAST PEAKVIEW AVENUE        SE DECISION MADE: 26-SEP-13
CENTENNIAL CO 80111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESTEYA
NUCLETRON B.V.                    510(k) NO: K132092(TRADITIONAL)
ATTN: LU ANNE  JOHNSON            PHONE NO : 715 403 5321   
1917 29 3/4 AVE.                  SE DECISION MADE: 26-SEP-13
RICE LAKE WI 54868                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS DXL 12/16-LEAD ECG ALGORITHM
PHILIPS MEDICAL SYSTEMS           510(k) NO: K132068(SPECIAL)
ATTN: THERESA  POOLE              PHONE NO : 978 659 7621   
3000 Minuteman Rd                 SE DECISION MADE: 26-SEP-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
ORFIT INDUSTRIES NV               510(k) NO: K131795(TRADITIONAL)
ATTN: EDDY  MARIVOET              PHONE NO : 320 33 262026
VOSVELD 9A                        SE DECISION MADE: 26-SEP-13
WIJNEGEM    BE 2110               510(k) STATEMENT

DEVICE: CG+ ARROW JACC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K132133(SPECIAL)
ATTN: JULIE  LAWSON               PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 26-SEP-13
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY ACETABULAR SYSTEM
CORIN USA                         510(k) NO: K131647(TRADITIONAL)
ATTN: DIANA L MARTONE             PHONE NO : 813 977 4469   
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 27-SEP-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THEYFIT MALE CONDOM
THEYFIT                           510(k) NO: K122219(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978   
717 LAKEGLEN DRIVE                SE DECISION MADE: 27-SEP-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY-GRAFT
DEGRADABLE SOLUTIONS AG           510(k) NO: K131385(TRADITIONAL)
ATTN: DEBORAH  LAVOIE GRAYESKI    PHONE NO : 703 562 9800   
901 KING STREET SUITE 101         SE DECISION MADE: 27-SEP-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOK CERVICAL RIPENING BALLOON
COOK, INC.                        510(k) NO: K131206(TRADITIONAL)
ATTN: CHIRS  KILANDER             PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 27-SEP-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
MATERIALISE N.V.                  510(k) NO: K131559(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 32 1639 6280
TECHNOLOGIELAAN 15                SE DECISION MADE: 27-SEP-13
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BESTFIT2 NASAL MASK
CURATIVE MEDICAL INC.             510(k) NO: K130663(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
6518 TAMARIND SKY LN.             SE DECISION MADE: 27-SEP-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER NAV3I PLATFORM
STRYKER CORPORATE                 510(k) NO: K130874(TRADITIONAL)
ATTN: LILIAN  ECKERT              PHONE NO : 49 761 4512117
BOETZINGER STR. 41                SE DECISION MADE: 27-SEP-13
FREIBURG, BADEN-WUERTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASTERTORQUE LUX 8900 L
KALTENBACH & VOIGT GMBH           510(k) NO: K130560(TRADITIONAL)
ATTN: STEFAN  TRAMPLER            PHONE NO : 49 7351 563515
BISMARCKRING 39                   SE DECISION MADE: 27-SEP-13
BIBERACH / RISS    GM 88400       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
HK SURGICAL, INC.                 510(k) NO: K123822(TRADITIONAL)
ATTN: CLARE  BENNETT              PHONE NO : 949 369 0101   
1271 PUERTA DEL SOL               SE DECISION MADE: 27-SEP-13
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
DEVON MEDICAL                     510(k) NO: K132252(SPECIAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103   
1100 FIRST AVENUE SUITE 202       SE DECISION MADE: 27-SEP-13
KING OF PRUSSIA PA 19406          510(k) STATEMENT

DEVICE: MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
MEDTRONIC INC.                    510(k) NO: K132030(TRADITIONAL)
ATTN: CHECHAMMA  VARUGHESE        PHONE NO : 763 523 2364   
8200 CORAL SEA STREET MS MVS11    SE DECISION MADE: 27-SEP-13
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K131618(TRADITIONAL)
ATTN: JOHN  CHESNEY               PHONE NO : 734 741 6410   
6200 JACKSON RD.                  SE DECISION MADE: 27-SEP-13
ANN ARBOR MI 48103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
VOLCANO CORPORATION               510(k) NO: K132659(SPECIAL)
ATTN: MARCUS  GARCIA              PHONE NO : 978 439 3312   
1 FORTUNE DRIVE                   SE DECISION MADE: 27-SEP-13
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
GE HEALTHCARE FINLAND OY          510(k) NO: K132696(SPECIAL)
ATTN: JOEL  KENT                  PHONE NO : 781 449 8685   
86 PILGRIM ROAD                   SE DECISION MADE: 27-SEP-13
NEEDHAM MA 02492                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
HANSEN MEDICAL, INC.              510(k) NO: K132369(SPECIAL)
ATTN: HASSAN  LABAY               PHONE NO : 650 404 5888   
800 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 27-SEP-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MORCELLEX SIGMA GENERATOR
ETHICON, INC.                     510(k) NO: K131656(TRADITIONAL)
ATTN: SARAH  MCMANUS              PHONE NO : 908 218 2954   
P.O. BOX 151 ROUTE 22 WEST        SE DECISION MADE: 27-SEP-13
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
US VASCULAR, LLC                  510(k) NO: K131860(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 27-SEP-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI COAXIAL MICROINTRODUCER SET
NAVILYST MEDICAL, INC.            510(k) NO: K132713(SPECIAL)
ATTN: MICHAEL P HANLEY            PHONE NO : 508 658 7983   
26 FOREST STREET                  SE DECISION MADE: 27-SEP-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX UNIVERS APEX
ARTHREX, INC.                     510(k) NO: K131633(TRADITIONAL)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 27-SEP-13
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
TYBER MEDICAL LLC                 510(k) NO: K130573(TRADITIONAL)
ATTN: JEFF  TYBER                 PHONE NO : 303 717 5060   
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 30-SEP-13
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
ACUMED LLC                        510(k) NO: K131845(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 30-SEP-13
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIRED MOUTH PROTECTOR (WMP)
ELBA LABORATORIES, INC.           510(k) NO: K131396(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 248 586 8433   
780 W. 8 MILE RD                  SE DECISION MADE: 30-SEP-13
FERNDALE MI 48220                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
NEOS SURGERY S.L.                 510(k) NO: K132044(TRADITIONAL)
ATTN: CHERITA  JAMES              PHONE NO : 703 562 9800   
901 KING STREET SUITE 101         SE DECISION MADE: 30-SEP-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
BEST MEDICAL INTERNATIONAL, INC.  510(k) NO: K132097(TRADITIONAL)
ATTN: DHARMENDRA  THAKUR          PHONE NO : 703 451 2378   
7643 FULLERTON RD.                SE DECISION MADE: 30-SEP-13
SPRINGFIELD VA 22153              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHASER HRS2 RX HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K132266(TRADITIONAL)
ATTN: ANTHONY  BURNS              PHONE NO : 781 995 2246   
10 MAGUIRE RD STE 120 BUILDING ONESE DECISION MADE: 30-SEP-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   218                                     
                                                 TOTAL WITH SUMMARIES        198                                     
                                                 TOTAL WITH STATEMENTS        20
                                      

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