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U.S. Department of Health and Human Services

Medical Devices

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May 2011 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2011


DEVICE: DURAFIBER AG
SMITH & NEPHEW, INC               510(k) NO: K103793(TRADITIONAL)
ATTN: TERRY  MCMAHON              PHONE NO : 727 392 1261   
970 LAKE CARILLON DRIVE, SUITE 110SE DECISION MADE: 02-MAY-11
ST. PETERSBURG FL 33716           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WEBSTER DUO-DECAPOLAR  CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K101991(TRADITIONAL)
ATTN: BALAKA  DAS                 PHONE NO : 909 839 8599   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 02-MAY-11
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K102191(ABBREVIATED)
ATTN: LEO  WANG                   PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 02-MAY-11
CHENGDU    CH 610041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DILON 6800 ACELLA (ACELLA)
DILON TECHNOLOGIES, INC.          510(k) NO: K110384(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 03-MAY-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: READY VIEW
GE HEALTHCARE (GE MEDICAL SYSTEMS 510(k) NO: K110573(TRADITIONAL)
ATTN: ELIZABETH  MATHEW           PHONE NO : 262 521 6658   
3200 N GRANDVIEW BLVD, W-827      SE DECISION MADE: 03-MAY-11
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
BIOMET SPORTS MEDICINE            510(k) NO: K110039(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 03-MAY-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEAR+BRILLIANT LASER SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K110349(TRADITIONAL)
ATTN: KRISTINE  FOSS              PHONE NO : 510 780 4657   
25881 INDUSTRIAL BLVD.            SE DECISION MADE: 03-MAY-11
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
ROCHE DIAGNOSTICS                 510(k) NO: K110446(TRADITIONAL)
ATTN: MICHELLE LEE  NEFF          PHONE NO : 317 521 2000   
9115 HAGUE ROAD                   SE DECISION MADE: 03-MAY-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
CORIN USA                         510(k) NO: K110087(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 03-MAY-11
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
NANOTHERAPEUTICS, INC.            510(k) NO: K110976(SPECIAL)
ATTN: DENNIS  TOMISAKA            PHONE NO : 386 462 9663   
13859 PROGRESS BLVD, SUITE 300    SE DECISION MADE: 03-MAY-11
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICON ADULT MANUAL
ICON WHEELCHAIRS INC              510(k) NO: K110985(TRADITIONAL)
ATTN: TOM  HORTON                 PHONE NO : 413 584 4491   
115 BRIDGE STREET                 SE DECISION MADE: 03-MAY-11
NORTHAMPTON MA 01060              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PICCOLO COMPOSITE NAILING SYSTEM
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K111056(SPECIAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET              SE DECISION MADE: 03-MAY-11
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMIER C. DIFFICILE GDH
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K110620(TRADITIONAL)
ATTN: SUSAN  BOGAR                PHONE NO : 513 271 3700   
3471 RIVER HILLS DR.              SE DECISION MADE: 03-MAY-11
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINNITUS SOUND GENERATOR MODULE
GN RESOUND A/S                    510(k) NO: K110932(SPECIAL)
ATTN: LARS  HAGANDER              PHONE NO : 45 457 51111
LAUTRUPBJERG 7                    SE DECISION MADE: 03-MAY-11
BALLERUP    DA 2750               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAC MALE ADAPTER
BIOMET TRAUMA (AKA EBI LLC)       510(k) NO: K102843(SPECIAL)
ATTN: MARGARET F CROWE            PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 03-MAY-11
PARISPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSILASER PAD-IQ
VASAMED, INC.                     510(k) NO: K110438(ABBREVIATED)
ATTN: GARY J SYRING               PHONE NO : 608 877 2635   
800 LEVANGER LANE                 SE DECISION MADE: 04-MAY-11
STOUGHTON WI 53589                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICK UP
VOCO GMBH                         510(k) NO: K110440(TRADITIONAL)
ATTN: DR. T.  GERKENSMEIER        PHONE NO : 494 721 719200
ANTON-FLETTNER-STR. 1-3           SE DECISION MADE: 04-MAY-11
CUXHAVEN    GM 27472              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFYMETRIX GENE PROFILING REAGENTS
AFFYMETRIX, INC.                  510(k) NO: K103112(TRADITIONAL)
ATTN: MAUREEN  MENDE              PHONE NO : 650 730 5020   
3 LAGOON DRIVE SUITE 160          SE DECISION MADE: 04-MAY-11
REDWOOD SHORES CA 94065           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K102324(TRADITIONAL)
ATTN: SARAH  HOLTGREWE            PHONE NO : 901 867 4476   
5677 AIRLINE RD.                  SE DECISION MADE: 04-MAY-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K102681(TRADITIONAL)
ATTN: MATTHEW  GEA                PHONE NO : 914 524 2099   
511 BENEDICT AVE.                 SE DECISION MADE: 04-MAY-11
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
GENOSS CO., LTD.                  510(k) NO: K102307(TRADITIONAL)
ATTN: EUNKYUNG  SON               PHONE NO : 714 895 7278   
11075 KNOTT AVE., SUITE A         SE DECISION MADE: 04-MAY-11
CYPRESS CA 90630                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
MEDTRONIC INC.                    510(k) NO: K103764(TRADITIONAL)
ATTN: YUKIKO  CORSON              PHONE NO : 763 526 3409   
8200 CORAL SEA ST NE              SE DECISION MADE: 04-MAY-11
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARDYCHROM MRSA
HARDY DIAGNOSTICS                 510(k) NO: K102922(TRADITIONAL)
ATTN: RENE  CLASEN                PHONE NO : 805 346 2766   
1430 WEST MCCOY LN.               SE DECISION MADE: 04-MAY-11
SANTA MARIA CA 93455              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HLS KNEETEC SYSTEM
TORNIER                           510(k) NO: K094013(SPECIAL)
ATTN: SEVERINE  BONNETON          PHONE NO : 003 347 6613500
161 RUE LAVOISIER                 SE DECISION MADE: 05-MAY-11
MONTBONNOT, SAINT-ISMIER    FR 383510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELYX LUTING PLUS AUTOMIX
3M ESPE DENTAL PRODUCTS           510(k) NO: K111185(TRADITIONAL)
ATTN: BERNARDO  MEDELLIN, J.D.    PHONE NO : 651 733 5718   
3M CENTER, BUILDING 260-2A-11     SE DECISION MADE: 05-MAY-11
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IE-ZEN (IN CLEAR SERIES HEARING AID)
WIDEX USA                         510(k) NO: K110973(SPECIAL)
ATTN: FRANCIS  KUK                PHONE NO : 630 245 0025   
2300 CABOT DRIVE, SUITE 415       SE DECISION MADE: 05-MAY-11
LISLE IL 60532                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN
INTERACOUSTICS A/S                510(k) NO: K103760(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 456 371 3555
DREJERVAENGET 8                   SE DECISION MADE: 05-MAY-11
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENODYNE V810
MICROTEK MEDICAL, INC.            510(k) NO: K110358(TRADITIONAL)
ATTN: TOM  BONNER                 PHONE NO : 888 844 0988   
602 LEHMBERG RD.                  SE DECISION MADE: 05-MAY-11
COLUMBUS MS 39702                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISSYS LP SPINAL FIXATION SYSTEM
CUSTOM SPINE, INC.                510(k) NO: K111099(SPECIAL)
ATTN: SAAD  ATTIYAH               PHONE NO : 973 265 5036   
1140 PARSIPPANY BLVD. SUITE 201   SE DECISION MADE: 05-MAY-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
MCKESSON INFORMATION SOLUTIONS LLC510(k) NO: K102263(TRADITIONAL)
ATTN: STEVEN B DATLOF             PHONE NO : 267 675 4613   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 05-MAY-11
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K110549(TRADITIONAL)
ATTN: DONNA R LUNAK               PHONE NO : 651 756 2944   
ONE ST JUDE MEDICAL DRIVE         SE DECISION MADE: 05-MAY-11
ST PAUL MN 55117 9913             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRICITY PACS
GE HEALTHCARE                     510(k) NO: K110875(TRADITIONAL)
ATTN: CHERYL  BORK                PHONE NO : 847 277 6038   
540 W. NORTHWEST HIGHWAY          SE DECISION MADE: 05-MAY-11
BARRINGTON IL 60010               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
HOWMEDICA OSTEONICS CORP          510(k) NO: K103835(TRADITIONAL)
ATTN: AVITAL  MERL-MARGULIES      PHONE NO : 201 831 6365   
325 CORPORATE DR.                 SE DECISION MADE: 05-MAY-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
GLOBUS MEDICAL INC.               510(k) NO: K110963(SPECIAL)
ATTN: KELLY J BAKER, PH.D         PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 05-MAY-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OWL RF PROBES
DIROS TECHNOLOGY, INC.            510(k) NO: K110593(SPECIAL)
ATTN: GEORGE  DARMOS              PHONE NO : 905 415 3440
232 HOOD ROAD                     SE DECISION MADE: 05-MAY-11
MARKHAM, ONTARIO    CA L3R 3K8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIOVISION
HAAS SOFTWARE                     510(k) NO: K111102(TRADITIONAL)
ATTN: DAVID L STARK               PHONE NO : 415 888 3700   
38 MILLER AVENUE PMB 170          SE DECISION MADE: 05-MAY-11
MILL VALLEY CA 94941              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
MICROPHAGE, INC.                  510(k) NO: K102342(TRADITIONAL)
ATTN: DREW  SMITH                 PHONE NO : 303 652 5049   
2400 TRADE CENTRE AVENUE          SE DECISION MADE: 05-MAY-11
LONGMONT CO 80503                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
SEPPIM S.A.S.                     510(k) NO: K100263(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 06-MAY-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIC INSTRUMENT PROCESSING SYSTEM
LANGFORD IC SYSTEMS, INC.         510(k) NO: K101158(TRADITIONAL)
ATTN: TERRY  LANGFORD             PHONE NO : 520 745 6201   
310 S. WILLIAMS BLVD. SUITE 270   SE DECISION MADE: 06-MAY-11
TUCSON AZ 85711                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE LUNAR VISCERAL FAT SOFTWARE
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K103730(TRADITIONAL)
ATTN: CHRIS  PAULIK               PHONE NO : 262 548 2010   
3030 OHMEDA DRIVE                 SE DECISION MADE: 06-MAY-11
MADISON WI 53718                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
COOK UROLOGICAL, INC.             510(k) NO: K102141(TRADITIONAL)
ATTN: CINDY  FOOTE                PHONE NO : 812 829 4891   
1100 WEST MORGAN ST.              SE DECISION MADE: 06-MAY-11
SPENCER IN 47460                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX MEDICAL WIZARD SERIES CPAP MASK
APEX MEDICAL CORP.                510(k) NO: K103174(TRADITIONAL)
ATTN: ALAN  CHANG                 PHONE NO : 886 222 683100
NO. 9, MINSHENG STREET            SE DECISION MADE: 06-MAY-11
TUCHENG CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URIC ACID MODEL 3P39
ABBOT LABORATORIES                510(k) NO: K102568(TRADITIONAL)
ATTN: LINDA K MORRIS              PHONE NO : 972 518 6711   
1921 HURD DRIVE                   SE DECISION MADE: 06-MAY-11
IRVING TX 75038                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUNITY
CLIENT OUTLOOK INC                510(k) NO: K111164(TRADITIONAL)
ATTN: CHRISTIE  EBY               PHONE NO : 519 342 6864
295 HAGEY BLVD                    SE DECISION MADE: 06-MAY-11
WATERLOO    CA N2L 6R5            510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: INDISTRIP GREEN
INDILAB, INC.                     510(k) NO: K110369(TRADITIONAL)
ATTN: MARK  ESPENSCHEID           PHONE NO : 847 928 1050   
10367 FRANKLIN AVE.               SE DECISION MADE: 06-MAY-11
FRANKLIN PARK IL 60131            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRA PERITONEAL DRAINAGE SYSTEM
C.R. BARD, INC.                   510(k) NO: K110396(SPECIAL)
ATTN: HENRY  BOLAND               PHONE NO : 801 595 0700   
605 NORTH 5600 WEST               SE DECISION MADE: 06-MAY-11
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
CARDINAL HEALTH, INC.             510(k) NO: K111015(TRADITIONAL)
ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   
1430  WAUKEGAN ROAD               SE DECISION MADE: 06-MAY-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
DIAMOND DIAGNOSTICS, INC          510(k) NO: K103364(TRADITIONAL)
ATTN: LIANN  VOO                  PHONE NO : 508 429 0450   
333 Fiske St                      SE DECISION MADE: 06-MAY-11
Holliston MA 01746                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNOVA WHEELCHAIR
COLUMBIA MEDICAL MANUFACTURING, LL510(k) NO: K110788(ABBREVIATED)
ATTN: SUSAN  JOHNSON              PHONE NO : 562 282 0244   
11724 WILLAKE STREET              SE DECISION MADE: 06-MAY-11
SANTA FE SPRINGS CA 90670         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMOND-FLEX(R) GRASPERS
CAREFUSION 2200, INC.             510(k) NO: K110257(TRADITIONAL)
ATTN: JANE  WEBER                 PHONE NO : 847 473 7429   
1500 WAUKEGAN ROAD                SE DECISION MADE: 06-MAY-11
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOGEN
ORTHOGEN, LLC                     510(k) NO: K102208(TRADITIONAL)
ATTN: HAROLD  ALEXANDER           PHONE NO : 973 467 2404   
505 MORRIS AVENUE, SUITE 104      SE DECISION MADE: 06-MAY-11
SPRINGFIELD NJ 07081              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOTUS BLAKE ESTEEM SCOOTER
LETRIX POWER HANGZHOU PTY LTD     510(k) NO: K103771(TRADITIONAL)
ATTN: ROBERT  DUNN                PHONE NO : 714 501 0080   
10352 STANFORD RD                 SE DECISION MADE: 06-MAY-11
GARDEN GROVE CA 92840             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORCETRIAD
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K102913(SPECIAL)
ATTN: BEN  CORDILEONE             PHONE NO : 303 530 2300   
5920 LONGBOW DRIVE                SE DECISION MADE: 06-MAY-11
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMAX SPECIMEN RETRIEVAL SYSTEM
UNIMAX MEDICAL SYSTEMS, INC.      510(k) NO: K103510(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 45, MINSHEN RD. DANSHUI TOWN  SE DECISION MADE: 06-MAY-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX METHAMPHETAMINE ASSAY
RANDOX LABORATORIES, LTD.         510(k) NO: K092266(TRADITIONAL)
ATTN: P  ARMSTRONG                PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 09-MAY-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103611(TRADITIONAL)
ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   
5976 HEISELY RD.                  SE DECISION MADE: 09-MAY-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODMAN BACTISEAL ENDOSCOPIC VENTICULAR; CODMAN BACTISEAL ENDOSCOPIC VENTRICULAR
CODMAN & SHURTLEFF, INC.          510(k) NO: K110751(TRADITIONAL)
ATTN: SHARON  MCDERMOTT           PHONE NO : 508 880 8349   
325 PARAMOUNT DR.                 SE DECISION MADE: 09-MAY-11
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIOPSYS NOVA VEP VISION TESTING SYSTEM
DIOPSYS INC.                      510(k) NO: K101763(TRADITIONAL)
ATTN: RICHARD  HETTENBACH         PHONE NO : 973 214 7468   
44 COUNTRYWOOD DRIVE              SE DECISION MADE: 09-MAY-11
PINE BROOK NJ 07058               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
MAQUET CRITICAL CARE AB           510(k) NO: K102182(ABBREVIATED)
ATTN: WHITNEY  TORNING            PHONE NO : 973 709 7994   
45 BORBOUR POND DRIVE             SE DECISION MADE: 09-MAY-11
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELOX RAPID GAUZE
MEDTECH PRODUCTS LTD.             510(k) NO: K110386(TRADITIONAL)
ATTN: JONATHAN  RANFIELD          PHONE NO : 441 270 500019
ELECTRA HOUSE, CREWE BUSINESS PARKSE DECISION MADE: 10-MAY-11
CHESHIRE    UK CW1 6GL            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEARL DIABETES MANAGEMENT SYSTEM
M2 GROUP HOLDINGS, INC.           510(k) NO: K100567(TRADITIONAL)
ATTN: NAGHMEH  NOURI              PHONE NO : 408 716 5652   
1012 STEWART DRIVE                SE DECISION MADE: 10-MAY-11
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
JOHNSON & JOHNSON CONSUMER & PERSO510(k) NO: K101585(TRADITIONAL)
ATTN: BRAD  LAMOTTE,PHARM.D.      PHONE NO : 973 385 3667   
185 TABOR ROAD                    SE DECISION MADE: 10-MAY-11
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNACOR LUBRICATION GEL
MEDLINE INDUSTRIES, INC.          510(k) NO: K103718(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PLACE                 SE DECISION MADE: 10-MAY-11
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
BRIDGE MEDICAL, INC.              510(k) NO: K102725(TRADITIONAL)
ATTN: JILL  MUNSINGER             PHONE NO : 763 225 8500   
2800 CAMPUS DR SUITE 50           SE DECISION MADE: 10-MAY-11
PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WEXLER ENDOSCOPE ACCESSORIES
MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110121(TRADITIONAL)
ATTN: LISA S JONES                PHONE NO : 713 664 6775   
540 COLLEGE STREET                SE DECISION MADE: 10-MAY-11
BELLAIRE TX 77401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORNIER BIOFIBER SCAFFOLD
TORNIER, INC.                     510(k) NO: K102788(TRADITIONAL)
ATTN: LAEL J PICKETT              PHONE NO : 952 426 7641   
100 CUMMINGS CENTER SUITE 444C    SE DECISION MADE: 10-MAY-11
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AGILIS NXT STEERABLE INTRODUCER
ST. JUDE MEDICAL                  510(k) NO: K110450(TRADITIONAL)
ATTN: WENDY  PINOR                PHONE NO : 651 756 5223   
14901 DEVEAU PLACE                SE DECISION MADE: 10-MAY-11
MINNETONKA MN 55345               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAHA 3 POWER SOUND PROCESSOR
COCHLEAR AMERICAS                 510(k) NO: K110996(SPECIAL)
ATTN: SEAN  BUNDY                 PHONE NO : 800 523 5798   
13059 E. PEAKVIEW AVE             SE DECISION MADE: 10-MAY-11
CENTENNIAL CO 80111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLADIATOR PLASMA CLASSIC HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K110399(TRADITIONAL)
ATTN: MATT  PAUL                  PHONE NO : 901 867 4350   
5677 AIRLINE RD.                  SE DECISION MADE: 10-MAY-11
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
TRUE GLOVE FACTORY                510(k) NO: K110314(TRADITIONAL)
ATTN: FRANK  YANG                 PHONE NO : 865 363 775588
NO.6-1 XINGAN ROAD EAST, LINQU    SE DECISION MADE: 10-MAY-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
ALCON RESEARCH, LTD.              510(k) NO: K102860(TRADITIONAL)
ATTN: BETH L SCHULTZ              PHONE NO : 817 568 6143   
6201 SOUTH FREEWAY                SE DECISION MADE: 10-MAY-11
FORT WORTH TX 76134 2099          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K100910(TRADITIONAL)
ATTN: DONNA  VELASQUEZ            PHONE NO : 310 645 8200   
5210 PACIFIC CONCOURSE DR.        SE DECISION MADE: 11-MAY-11
LOS ANGELES CA 90045 6900         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD.    510(k) NO: K103523(SPECIAL)
ATTN: AMY  PIEPER                 PHONE NO : 512 873 0033   
8508 CROSS PARK DR.               SE DECISION MADE: 11-MAY-11
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD.    510(k) NO: K103525(SPECIAL)
ATTN: AMY  PIEPER                 PHONE NO : 512 873 0033   
8508 CROSS PARK DR.               SE DECISION MADE: 11-MAY-11
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACHILLES
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K103633(TRADITIONAL)
ATTN: CHRIS  PAULIK               PHONE NO : 262 548 2010
NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 11-MAY-11
WUXI, JIANGSU PROVINCE    CH 21402510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA LED SURGICAL HEADLIGHT SYSTEM
INTEGRA LIFE SCIENCES CORPORATION 510(k) NO: K110528(TRADITIONAL)
ATTN: STEPHANIE  SHEESLEY         PHONE NO : 717 840 2774   
589 DAVIES DRIVE                  SE DECISION MADE: 11-MAY-11
YORK PA 17402                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K110965(TRADITIONAL)
ATTN: DAVID J COLLETTE, MD        PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 11-MAY-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRA PLEURAL DRAINAGE SYSTEM
C.R. BARD, INC.                   510(k) NO: K110409(SPECIAL)
ATTN: HENRY  BOLAND               PHONE NO : 801 595 0700   
605 NORTH 5600 WEST               SE DECISION MADE: 11-MAY-11
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
BECKMAN COULTER, INC.             510(k) NO: K110413(SPECIAL)
ATTN: MARINE  BOYAJIAN            PHONE NO : 714 961 6536   
250 SOUTH KRAEMER BLVD            SE DECISION MADE: 11-MAY-11
BREA CA 92822                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOLPHIN IMAGING
PATTERSON DENTAL SUPPLY, INC.     510(k) NO: K110430(TRADITIONAL)
ATTN: DAWN  LI                    PHONE NO : 651 905 3203   
1031 MENDOTA HEIGHTS RD.          SE DECISION MADE: 11-MAY-11
ST. PAUL MN 55120                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AURADORM (NEUROMUSCULAR SLEEP)
SLEEPWRIGHT                       510(k) NO: K101155(TRADITIONAL)
ATTN: CYNTHIA  WRIGHT             PHONE NO : 505 989 7866   
27 TIMBERWICK RD                  SE DECISION MADE: 12-MAY-11
SANTA FE NM 87508                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
ROCHE DIAGNOSTICS                 510(k) NO: K103716(SPECIAL)
ATTN: KATHIE J GOODWIN            PHONE NO : 317 521 3831   
9115 HAGUE ROAD                   SE DECISION MADE: 12-MAY-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MUSTANG BALLOON DILATAION CATHETERS
BOSTON SCIENTIFIC                 510(k) NO: K110122(TRADITIONAL)
ATTN: ANNE V ROSSI                PHONE NO : 763 255 0681   
ONE SCIMED PLACE                  SE DECISION MADE: 12-MAY-11
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE TL SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K110692(SPECIAL)
ATTN: EMILY M DOWNS               PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 12-MAY-11
MARQUETTE MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DROPPER A1C DIABETES CONTROL
QUANTIMETRIX CORP.                510(k) NO: K103744(TRADITIONAL)
ATTN: KALYNA  SNYLYK              PHONE NO : 310 536 0006   
2005 MANHATTAN BEACH BLVD.        SE DECISION MADE: 12-MAY-11
REDONDO BEACH CA 90278 1205       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVEA VENTILATOR
CAREFUSION                        510(k) NO: K103211(TRADITIONAL)
ATTN: FAROKH  ETEMADIEH           PHONE NO : 714 922 7615   
22745 SAVI RANCH PARKWAY          SE DECISION MADE: 12-MAY-11
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UPD-Y0003
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103312(TRADITIONAL)
ATTN: STACY  KLUESNER             PHONE NO : 484 896 5405   
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 12-MAY-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEASPINE SPACER SYSTEM
SEASPINE, INC.                    510(k) NO: K102026(TRADITIONAL)
ATTN: DAN  MILLER                 PHONE NO : 760 727 8399   
2301 LA MIRADA DR                 SE DECISION MADE: 12-MAY-11
VISTA CA 92081                    510(k) STATEMENT

DEVICE: ACTIVECARE SFT
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K110159(TRADITIONAL)
ATTN: ORLY  MAOR                  PHONE NO : 972 974 53607
25 A SIRKIN STREET                SE DECISION MADE: 12-MAY-11
KFAR SABA    IS 44421             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS PROLACTIN II CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K110613(TRADITIONAL)
ATTN: KELLY COLLEEN  O'MAINE ADAMSPHONE NO : 317 521 3577   
9115 HAGUE ROAD                   SE DECISION MADE: 12-MAY-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLEABI
NEWMAN MEDICAL                    510(k) NO: K110628(TRADITIONAL)
ATTN: SPENCER  NEWMAN             PHONE NO : 847 283 9177   
42 SHERWOOD TERRACE SUITE 2       SE DECISION MADE: 12-MAY-11
LAKE BLUFF IL 60044               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: CLEARBLUE EASY PREGNANCY TEST
SPD DEVELOPMENT COMPANY LIMITED   510(k) NO: K110433(SPECIAL)
ATTN: TANYA  FAIR                 PHONE NO : 440 123 4835290
STANNARD WAY PRIORY BUSINESS PARK SE DECISION MADE: 12-MAY-11
BEDFORD,  BEDFORDSHIRE    UK MK44 510(k) STATEMENT

DEVICE: INVADER MTHFR 677
HOLOGIC, INC.                     510(k) NO: K100987(TRADITIONAL)
ATTN: RANDALL  COVILL             PHONE NO : 508 263 8853   
250 CAMPUS DRIVE                  SE DECISION MADE: 13-MAY-11
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN KAIYUE GLOVE CO., LTD.   510(k) NO: K110146(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM 1606 BLDG 1 JIANXIANG YUAN NO 2SE DECISION MADE: 13-MAY-11
HAIDIAN DISTRICT, BEIJING    CH 10510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COUGAR LS LATERAL CAGE SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K110454(SPECIAL)
ATTN: KEVIN G STEVENS             PHONE NO : 508 977 6445   
325 PARAMOUNT DR.                 SE DECISION MADE: 13-MAY-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL PACIFIER THERMOMETER
ABERTEK                           510(k) NO: K103407(TRADITIONAL)
ATTN: TANI  MOK                   PHONE NO : 867 558 1436181
4F, BLOCK 4, FU YUAN IND. ZONE JUISE DECISION MADE: 13-MAY-11
SHENZHEN, GUANG DONG PROVINCE    C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO SUPPORT CATHETER
TERUMO MEDICAL CORP.              510(k) NO: K110540(TRADITIONAL)
ATTN: MARK  UNTERREINER           PHONE NO : 410 392 7213   
950 ELKTON BLVD.                  SE DECISION MADE: 13-MAY-11
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
AEROGEN LTD                       510(k) NO: K103635(SPECIAL)
ATTN: MARTHA  FOLAN               PHONE NO : 353 91 502550
GALWAY BUSINESS PARK, DANGAN      SE DECISION MADE: 13-MAY-11
GALWAY    EI GALWAY               510(k) STATEMENT

DEVICE: VR MEDICAL ENTERAL ORAL SYRINGE
VR MEDICAL                        510(k) NO: K110853(TRADITIONAL)
ATTN: LEE  PAN                    PHONE NO : 
90 GAO XIN ROAD                   SE DECISION MADE: 13-MAY-11
ZHOUZHUANG    CH 215325           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ANGIODYNAMICS, INC. VENACURE 1470 LASER
ANGIODYNAMICS, INC.               510(k) NO: K110225(TRADITIONAL)
ATTN: TERI  JUCKETT               PHONE NO : 518 795 1142   
14 PLAZA DRIVE                    SE DECISION MADE: 13-MAY-11
LATHAM NY 12110                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTIBOND MULTI
SHOFU DENTAL CORP.                510(k) NO: K110235(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DR.                    SE DECISION MADE: 13-MAY-11
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: HI-DOW-XP
HI-DOW INTERNATIONAL INC.         510(k) NO: K102598(TRADITIONAL)
ATTN: ERIC  CHEN                  PHONE NO : 314 569 2888   
2071 CONGRESSIONAL DR             SE DECISION MADE: 13-MAY-11
ST LOUIS MO 63146                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
PREVENTIVE CARE, INC.             510(k) NO: K110102(TRADITIONAL)
ATTN: ANIL  SEGAT                 PHONE NO : 651 322 9120   
15215 BOULDER TRAIL               SE DECISION MADE: 13-MAY-11
ROSEMOUNT MN 55068                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEAUTIBOND MULTI PR PLUS
SHOFU DENTAL CORP.                510(k) NO: K110252(TRADITIONAL)
ATTN: DAVID P MORAIS              PHONE NO : 760 736 3277   
1225 STONE DR.                    SE DECISION MADE: 13-MAY-11
SAN MARCOS CA 92078               510(k) STATEMENT

DEVICE: ELECTRONIC SPHYGMOMANOMETER
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K110774(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 13-MAY-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEISENBERG DYEING LIQUIDS
3M ESPE AG                        510(k) NO: K111257(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 13-MAY-11
SEEFELD    GM 82229               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
PROXY BIOMEDICAL LTD.             510(k) NO: K111121(SPECIAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 13-MAY-11
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOBON XENOGRAFT GRANULES
BIOMET 3I                         510(k) NO: K110449(TRADITIONAL)
ATTN: MARTHA I GARAY              PHONE NO : 561 776 6923   
4555 RIVERSIDE DRIVE              SE DECISION MADE: 13-MAY-11
PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K102328(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 13-MAY-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTH CARE SYSTEM SOFTWARE
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K110948(SPECIAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 13-MAY-11
NEW TAIPEI COUNTY    TW 24888     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD.                   510(k) NO: K111227(TRADITIONAL)
ATTN: YUKITOSHI  KIYOMURA         PHONE NO : 81 422 455595
10 FAIRFIELD BLVD.                SE DECISION MADE: 13-MAY-11
WALLINGFORD CT 06492 7502         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CLICK-IT
TP ORTHODONTICS, INC.             510(k) NO: K111234(TRADITIONAL)
ATTN: ROBIN  INTAGLIATA           PHONE NO : 219 785 2591   
100 CENTER PLAZA                  SE DECISION MADE: 13-MAY-11
LA PORTE IN 46350 0073            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BD SINGLE USE, HYPODERMIC SYRINGE
BECTON, DICKINSON AND COMPANY     510(k) NO: K110771(SPECIAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
1 BECTON DRIVE MC237              SE DECISION MADE: 13-MAY-11
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC SPHYGMOMANOMETER
CONTEC MEDICAL SYSTEMS CO., LTD.  510(k) NO: K110775(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-423                  SE DECISION MADE: 13-MAY-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.VIA WEB VIEWER
SIEMENS AG, MEDICAL SOLUTIONS     510(k) NO: K111079(TRADITIONAL)
ATTN: SVEN  KNOKE                 PHONE NO : 49 913 1844687
HENKESTRASSE 127                  SE DECISION MADE: 13-MAY-11
ERLANGEN    GM D-91052            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DIMENSIONS HB1C KIT, MODEL DF105A
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K102510(TRADITIONAL)
ATTN: ANNA MARIE  ENNIS           PHONE NO : 302 631 9352   
500 GBC DRIVE PO BOX 6101         SE DECISION MADE: 13-MAY-11
NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
RAPID BIOMEDICAL GMBH             510(k) NO: K102748(ABBREVIATED)
ATTN: ARMIN  PUREA                PHONE NO : 49 936 588260
KETTELERSTR. 3-11 TECHNOLOGIEPARK SE DECISION MADE: 13-MAY-11
RIMPAR, BAVARIA    GM 97222       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BT-350
BISTOS CO., LTD.                  510(k) NO: K103545(TRADITIONAL)
ATTN: STEVE  KOHN                 PHONE NO : 718 339 6212   
4802 GLENWOOD ROAD                SE DECISION MADE: 13-MAY-11
BROOKLYN NY 11234                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
GIVEN IMAGING LTD.                510(k) NO: K103025(TRADITIONAL)
ATTN: TIM  THOMAS                 PHONE NO : 770 662 0870
P.O. BOX 258 NEW INDUSTRIAL PARK  SE DECISION MADE: 13-MAY-11
YOQNEAM    IS 20692               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAHE FIXATION PLATE AND SCREW SYSTEM
MAHE MEDICAL GMBH                 510(k) NO: K102845(TRADITIONAL)
ATTN: ANDREA  PECSI               PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5              SE DECISION MADE: 13-MAY-11
TUTTLINGEN, BW    GR 78532        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPUTED RADDIOGRAPHY SCANNER
3DISC AMERICAS                    510(k) NO: K102619(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 13-MAY-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
NATUS MEDICAL INCORPORATED        510(k) NO: K103589(TRADITIONAL)
ATTN: JULIE  FREED                PHONE NO : 800 426 0353   
5900 FIRST AVENUE SOUTH           SE DECISION MADE: 13-MAY-11
 SEATTLE WA 98108                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
ZOLL MEDICAL CORPORATION          510(k) NO: K103473(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH         PHONE NO : 978 421 9786   
269 MILL ROAD                     SE DECISION MADE: 13-MAY-11
CHELMSFORD MA 01824               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONESTEP PEDIATRIC MFE'S
ZOLL MEDICAL CORPORATION          510(k) NO: K110978(ABBREVIATED)
ATTN: ROBERT  MORSE               PHONE NO : 866 639 0060   
525 NARRAGANSETT PARK DRIVE       SE DECISION MADE: 13-MAY-11
PAWTUCKET RI 02861                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRATUS CS ACUTE CARE D-DIMER
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K110303(TRADITIONAL)
ATTN: KATHLEEN ANN  DRAY-LYONS    PHONE NO : 781 826 4551   
500 GBC DRIVE PO BOX 6101         SE DECISION MADE: 16-MAY-11
NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
MITSUBISHI CHEMICAL MEDIENCE CO   510(k) NO: K100130(TRADITIONAL)
ATTN: JUDI  SMITH                 PHONE NO : 410 592 2060   
PO BOX 103                        SE DECISION MADE: 16-MAY-11
BALDWIN MD 21013                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K110510(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 64264467
P.O. BOX 237-023                  SE DECISION MADE: 16-MAY-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
JPI HEALTHCARE CO., LTD           510(k) NO: K101779(TRADITIONAL)
ATTN: WILLIAM  LITTLE             PHONE NO : 516 513 1330   
170-5 Guro-3 Dong, #608 KURO-GU   SE DECISION MADE: 16-MAY-11
Seoul    KS 152-847               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
PERCUTANEOUS SYSTEMS, INC.        510(k) NO: K102887(TRADITIONAL)
ATTN: THOMAS  LAWSON, PHD         PHONE NO : 650 493 4200   
3260 HILLVIEW AVE.                SE DECISION MADE: 16-MAY-11
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNATURE PLANNER / SIGNATURE GUIDES
MATERIALISE N.V.                  510(k) NO: K110415(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVANA       PHONE NO : 321 639 6280
15 TECHNOLOGIELAAN                SE DECISION MADE: 16-MAY-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
OPTOMED OY                        510(k) NO: K110986(TRADITIONAL)
ATTN: LAURA  PIILA                PHONE NO : 358 207 413380
HALLITUSKATU 13-17 D 96           SE DECISION MADE: 16-MAY-11
OULU    FI 90100                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FUJINON ULTRASONIC PROCESSOR
FUJINON INC.                      510(k) NO: K111243(SPECIAL)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602 3568   
419 WEST AVENUE                   SE DECISION MADE: 16-MAY-11
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
BIOMERIEUX SA                     510(k) NO: K102535(TRADITIONAL)
ATTN: ASA  KARLSSON               PHONE NO : 330 478 875389
5 RUE DES AQUEDUCS                SE DECISION MADE: 16-MAY-11
CRAPONNE    FR 69290              510(k) STATEMENT

DEVICE: CHITOGAUZE FUSION
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K111163(SPECIAL)
ATTN: KENDRA  RATHKEY             PHONE NO : 503 245 0459   
10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 17-MAY-11
PORTLAND OR 97223 4363            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
EXACTECH, INC.                    510(k) NO: K110706(TRADITIONAL)
ATTN: GRAHAM L CUTHBERT           PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 17-MAY-11
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K103094(TRADITIONAL)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 756 4386   
ONE EDWARDS WAY                   SE DECISION MADE: 17-MAY-11
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
NOVOCOL, INC.                     510(k) NO: K110484(TRADITIONAL)
ATTN: CORA  BRACHO-TROCONIS       PHONE NO : 303 665 7535   
416 SOUTH TAYLOR AVE.             SE DECISION MADE: 17-MAY-11
LOUISVILLE CO 80027               510(k) STATEMENT

DEVICE: MAC 600 RESTING ECG ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103765(TRADITIONAL)
ATTN: JOE  LUCAS                  PHONE NO : 414 721 2594   
9900 INOVATION DRIVE              SE DECISION MADE: 17-MAY-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RPS ADENO DETECTOR PLUS
RAPID PATHOGEN SCREENING, INC.    510(k) NO: K110722(TRADITIONAL)
ATTN: DOUGLAS  BUESCHEL           PHONE NO : 941 556 1850   
7227 DELAINEY COURT               SE DECISION MADE: 17-MAY-11
SARASOTA FL 34240                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
DIAZYME LABORATORIES              510(k) NO: K110188(SPECIAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 17-MAY-11
POWAY CA 92064                    510(k) STATEMENT

DEVICE: COLONCAD API 3.1
MEDICSIGHT PLC                    510(k) NO: K083423(TRADITIONAL)
ATTN: AMARJIT  GILL               PHONE NO : 440 207 6057954
66 HAMMERSMITH ROAD               SE DECISION MADE: 17-MAY-11
LONDON    UK W148UD               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILE STORM (R) OPERATING KIT
INTELLIGENT ORTHOPAEDICS LTD      510(k) NO: K111001(SPECIAL)
ATTN: PETER J OGRODNIK            PHONE NO : 448 448 004405
STAFFORDSHIRE UNIVERSITY BUSINESS SE DECISION MADE: 17-MAY-11
STOKE ON TRENT, STAFFORDSHIRE    U510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMOTE VIEW SOFTWARE
CARIESCAN LTD.                    510(k) NO: K111321(SPECIAL)
ATTN: NIKOLA  SKELLY              PHONE NO : 440 138 2560910
UNIT 5 GATEWAY WEST, LUNA PLACE, TSE DECISION MADE: 17-MAY-11
DUNDEE, ANGUS    UK DD2 1XZ       510(k) STATEMENT

DEVICE: DASH KNEE
BRAINLAB AG                       510(k) NO: K102251(SPECIAL)
ATTN: ALEXANDER  SCHWIERSCH       PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 17-MAY-11
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IQ VENTILATION NASAL MASK
SLEEPNET CORPORATION              510(k) NO: K102317(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 17-MAY-11
BONITA SPRINGS FL 34134 2958      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
BRIVANT, LTD.                     510(k) NO: K103377(SPECIAL)
ATTN: TOMAS  FUREY                PHONE NO : 353 913 85037
PARKMORE WEST BUSINESS PARK       SE DECISION MADE: 18-MAY-11
GALWAY    EI EI                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
VISION-SCIENCES, INC.             510(k) NO: K102733(TRADITIONAL)
ATTN: LILLIAN  QUINTERO           PHONE NO : 845 365 0600   
40 RAMLAND RD. SOUTH              SE DECISION MADE: 18-MAY-11
ORANGEBURG NY 10962               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROG SUTURE ANCHOR 5.5MM, 2.9MM
ROG SPORTS MEDICINE, INC.         510(k) NO: K110229(TRADITIONAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 18-MAY-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
BIOMET MICROFIXATION, INC.        510(k) NO: K110574(SPECIAL)
ATTN: SHERYL  MALMBERG            PHONE NO : 904 741 9465   
1520 TRADEPORT DR.                SE DECISION MADE: 18-MAY-11
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OIS SYMPHONY IMAGE MANAGMENT SYSTEM
OPHTHALMIC IMAGING SYSTEMS        510(k) NO: K110006(TRADITIONAL)
ATTN: ANDREA  AMBROSE             PHONE NO : 916 646 2020   
221 LATHROP WAY, SUITE I          SE DECISION MADE: 18-MAY-11
SACRAMENTO CA 95815               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHASER IPL HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K103560(TRADITIONAL)
ATTN: GLEN  EMELOCK               PHONE NO : 781 665 9893   
32 HARRISON ST.                   SE DECISION MADE: 18-MAY-11
MELROSE MA 02176                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDAS TOXO IGG AVIDITY
BIOMERIEUX, INC.                  510(k) NO: K101946(TRADITIONAL)
ATTN: MARLENE  CHAVAROCHE         PHONE NO : 314 731 8385   
595 ANGLUM RD.                    SE DECISION MADE: 18-MAY-11
HAZELWOOD MO 63042                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGERPAW SYSTEM II
LAAX, INC.                        510(k) NO: K111064(SPECIAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 925 254 5228   
8 SNOWBERRY COURT                 SE DECISION MADE: 18-MAY-11
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MITRA-LIFT
SCIENCITY CO., LTD                510(k) NO: K103812(TRADITIONAL)
ATTN: JOYCE  BANG                 PHONE NO : 714 525 0114   
325 N. PUENTE ST. UNIT B          SE DECISION MADE: 18-MAY-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES HEMOSTATIC BONE PUTTY (HBP)
SYNTHES USA PRODUCTS, LLC         510(k) NO: K103822(TRADITIONAL)
ATTN: JEFFREY L DOW               PHONE NO : 484 356 9720   
1230 WILSON BLVD.                 SE DECISION MADE: 19-MAY-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
SEPPIM S.A.S.                     510(k) NO: K100547(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 19-MAY-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARK CARE DIABETES MANAGMENT SYSTEM
ARKRAY FACTORY USA, INC.          510(k) NO: K110709(TRADITIONAL)
ATTN: TYLER  FOUTCH               PHONE NO : 952 646 3171   
5182 WEST 76TH ST.                SE DECISION MADE: 19-MAY-11
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER PATIENT SPECIFIC CUTTING GUIDE
STRYKER CORP.                     510(k) NO: K110533(TRADITIONAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201 831 5718   
325 CORPORATE DRIVE               SE DECISION MADE: 19-MAY-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROG KNOTLESS SUTURE ANCHOR
ROG SPORTS MEDICINE, INC.         510(k) NO: K110230(TRADITIONAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 19-MAY-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZENIUS SPINAL SYSTEM
MEDYSSEY CO., LTD.                510(k) NO: K110283(SPECIAL)
ATTN: PATRICK  MOORE              PHONE NO : 801 266 4811   
6170 SOUTH 380 WEST SUITE 200     SE DECISION MADE: 19-MAY-11
MURRAY UT 84107                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
SEPPIM S.A.S.                     510(k) NO: K102993(TRADITIONAL)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 19-MAY-11
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
ZIMMER, INC.                      510(k) NO: K111039(SPECIAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 574 372 4944   
P.O. BOX 708                      SE DECISION MADE: 19-MAY-11
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADHESIVE EXL-759
3M ESPE AG                        510(k) NO: K110302(TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 19-MAY-11
SEEFELD, BAVARIA    GM D-82229    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERAMIC BRACKETS
ORTHO ORGANIZERS, INC.            510(k) NO: K110335(TRADITIONAL)
ATTN: FOSTER  BOOP                PHONE NO : 760 448 8600   
1822 ASTON AVENUE                 SE DECISION MADE: 19-MAY-11
CARLSBAD CA 92008 7603            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMAX SUCTION IRRIGATION SET
UNIMAX MEDICAL SYSTEMS, INC.      510(k) NO: K103509(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995
NO. 45, MINSHEN RD. DANSHUI TOWN  SE DECISION MADE: 19-MAY-11
TAIPEI COUNTY    TW 251           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHOENIX HEMODIALYSIS DELIVERY SYSTEM
GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K103832(TRADITIONAL)
ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 20-MAY-11
LAKEWOOD CO 80401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
MEDICA CORP.                      510(k) NO: K101090(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 20-MAY-11
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: CLEARCUT S SAFETY KNIFE
ALCON RESEARCH, LTD.              510(k) NO: K110166(ABBREVIATED)
ATTN: TONYA  MORGAN               PHONE NO : 817 551 8723   
6201 SOUTH FREEWAY                SE DECISION MADE: 20-MAY-11
FORT WORTH TX 76134 2099          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SICAT IMPLANT V1.2
SICAT GMBH & CO. KG               510(k) NO: K103723(TRADITIONAL)
ATTN: MARK W SHEEHAN              PHONE NO : 508 316 7151   
49 PLAIN STREET                   SE DECISION MADE: 20-MAY-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFTKAR PT
SANO TRANSPORTGERATE GMBH         510(k) NO: K110495(TRADITIONAL)
ATTN: JEANINE A CARROCCIO         PHONE NO : 630 891 2817   
4028 BELLEAIRE LANE               SE DECISION MADE: 20-MAY-11
DOWNERS GROVE IL 60515            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K103603(TRADITIONAL)
ATTN: EWA  NADOLCZAK              PHONE NO : 908 526 3744   
200 EVANS WAY                     SE DECISION MADE: 20-MAY-11
BRANCHBURG NJ 08876               510(k) STATEMENT

DEVICE: WITHINGS BLOOD PRESSURE MONITOR
WITHINGS                          510(k) NO: K110872(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 3 5208829
NO.58, FU CHIUN STREET            SE DECISION MADE: 20-MAY-11
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO NEURO PBV-IR
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111052(SPECIAL)
ATTN: GARY L JOHNSON              PHONE NO : 610 448 1778   
51 VALLEY STREAM PKWY. MAIL CODE GSE DECISION MADE: 20-MAY-11
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABS BLOWER, ABS NOZZLE, MODEL 1001
NIMBIC SYSTEMS, LLC               510(k) NO: K092801(TRADITIONAL)
ATTN: SEAN  SELF                  PHONE NO : 281 565 5700   
4910 WRIGHT ROAD, SUITE 170       SE DECISION MADE: 20-MAY-11
STAFFORD TX 77477                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESIGNS VSI VITAL SIGNS MONITOR
PHILIPS MEDICAL SYSTEMS           510(k) NO: K110803(TRADITIONAL)
ATTN: MARY  KRUITWAGEN            PHONE NO : 978 659 4932   
3000 MINUTEMAN RD.                SE DECISION MADE: 20-MAY-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESIGNS VS2 VITAL SIGNS MONITOR
PHILIPS MEDICAL SYSTEMS           510(k) NO: K111114(SPECIAL)
ATTN: KRISTEN  LESSARD            PHONE NO : 978 659 4219   
3000 MINUTEMAN ROAD               SE DECISION MADE: 20-MAY-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANNABINOIDS URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K110182(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 20-MAY-11
GAITHERSBURG MD 20877             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITALSENS, AINGEAL, V-POD
INTELESENS LIMITED                510(k) NO: K110015(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 20-MAY-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERCONTINENTAL PLATE-SPACER
GLOBUS MEDICAL INC.               510(k) NO: K103382(TRADITIONAL)
ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 20-MAY-11
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
MAR COR PURIFICATION, INC.        510(k) NO: K110578(TRADITIONAL)
ATTN: BRENT  GEIGER               PHONE NO : 763 553 3345   
14605 28TH AVENUE NORTH           SE DECISION MADE: 20-MAY-11
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K2M COCR WIRE
K2M, INC.                         510(k) NO: K103797(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 20-MAY-11
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER COLLA-PAD MODEL CS 03030
CORELEADER BIOTECH CO., LTD.      510(k) NO: K102946(TRADITIONAL)
ATTN: IAN  LI                     PHONE NO : 886 226 968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 20-MAY-11
TAIPEI, TAIWAN    TW 22102        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS Q FEVER DETECTION KIT
IDAHO TECHNOLOGY, INC.            510(k) NO: K103207(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 20-MAY-11
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXSALT SD7 WOUND DRESSING
EXCITON TECHNOLOGIES INC.         510(k) NO: K103067(TRADITIONAL)
ATTN: ROD  PRECHT                 PHONE NO : 780 248 5868
SUITE 4232, 10230 JASPER AVE      SE DECISION MADE: 20-MAY-11
EDMONTON    CA T5J 4P6            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPOTHERMX INTRAVENOUS FLUID WARMER
EMIT CORPORATION                  510(k) NO: K103801(TRADITIONAL)
ATTN: DARLA J ELKIN               PHONE NO : 281 450 8163   
42 NORTH CHATSONG CIRCLE          SE DECISION MADE: 20-MAY-11
WOODLANDS TX 77382                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
BIOMERIEUX, INC.                  510(k) NO: K102740(TRADITIONAL)
ATTN: JOCELYN  JENNINGS           PHONE NO : 919 620 2894   
100 RODOLPHE ST                   SE DECISION MADE: 20-MAY-11
DURHAM NC 27712                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RMS SUBCUTANEOUS NEEDLE SET
REPRO-MED SYSTEMS, INC.           510(k) NO: K102512(TRADITIONAL)
ATTN: ANDREW  SEALFON             PHONE NO : 845 469 2042   
24 CARPENTER RD.                  SE DECISION MADE: 20-MAY-11
CHESTER NY 10918                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
GYRUS ACMI, INC.                  510(k) NO: K102970(TRADITIONAL)
ATTN: LORRAINE  CALZETTA          PHONE NO : 508 804 2752   
136 TURNPIKE RD.                  SE DECISION MADE: 20-MAY-11
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROFIX VASO SHIELD
MIMEDX GROUP INC                  510(k) NO: K111137(SPECIAL)
ATTN: SALLY  THORSEN              PHONE NO : 678 384 6720   
811 LIVINGSTON COURT SE           SE DECISION MADE: 20-MAY-11
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
EPS BIO TECHNOLOGY CORP.          510(k) NO: K101037(TRADITIONAL)
ATTN: YC  LEI                     PHONE NO : 886 366 86868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 23-MAY-11
HSINCHU CITY    TW 30077          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE EMBOLIC FILTER
W.L. GORE & ASSOCIATES,INC        510(k) NO: K103500(TRADITIONAL)
ATTN: MICHELLE A WELLS            PHONE NO : 800 437 8181   
4250 WEST KILTIE LANE             SE DECISION MADE: 23-MAY-11
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K110676(SPECIAL)
ATTN: KEVIN  FORD                 PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 23-MAY-11
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GELPOINT PATH
APPLIED MEDICAL RESOURCES CORP.   510(k) NO: K110792(TRADITIONAL)
ATTN: FRANS  VANDENBROEK          PHONE NO : 949 713 8369   
22872 AVENIDA EMPRESA             SE DECISION MADE: 23-MAY-11
RANCHO SANTA MARGARITA CA 92688   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
BIOTRONIK, INC.                   510(k) NO: K111154(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 23-MAY-11
LAKE OSWEGO OR 97035              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN XIANGRUI PLASTIC PRODUCTS510(k) NO: K110155(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
ROOM 1606 BLDG.1JIANXIANG YUAN NO.SE DECISION MADE: 23-MAY-11
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
SOPHONO, INC                      510(k) NO: K102199(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 832 8200   
555 ZANG STREET SUITE 100         SE DECISION MADE: 23-MAY-11
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIT LAMP SL-2G
TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K110489(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 23-MAY-11
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
AZE, LTD.                         510(k) NO: K102534(TRADITIONAL)
ATTN: ANDY  ANDERSON              PHONE NO : 952 746 8079   
5353 WAYZATA BLVD. SUITE 505      SE DECISION MADE: 24-MAY-11
MINNEAPOLIS MN 55416 1334         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K111230(TRADITIONAL)
ATTN: REBECCA  BLANK              PHONE NO : 610 719 1268   
1301 GOSHEN PKWY.                 SE DECISION MADE: 24-MAY-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
C.R. BARD, INC.                   510(k) NO: K111153(SPECIAL)
ATTN: ZHENG  LIU                  PHONE NO : 401 825 8671   
100 CROSSINGS BOULEVARD           SE DECISION MADE: 24-MAY-11
WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4D LV-ANALYSIS 3.0
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K110746(TRADITIONAL)
ATTN: INGE  SCHEIDT               PHONE NO : 498 932 175515
EDISONSTRASSE 6                   SE DECISION MADE: 24-MAY-11
UNTERSCHLEISSHEIM    GM D-85716   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTAL SHOULDER SYSTEM
SHOULDER INNOVATIONS, LLC         510(k) NO: K110905(SPECIAL)
ATTN: ANDREW  RODENHOUSE          PHONE NO : 616 706 3903   
4670 FULTON STREET EAST           SE DECISION MADE: 24-MAY-11
ADA MI 49301                      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOJET SOLENT OMNI THROMBECTOMY SET
MEDRAD, INC.                      510(k) NO: K111182(SPECIAL)
ATTN: DOUG  ATKINS                PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD NW            SE DECISION MADE: 24-MAY-11
MINNEAPOLIS MN 55433 8003         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
ORTHOFIX INC.                     510(k) NO: K111183(SPECIAL)
ATTN: DARLA  CHEW                 PHONE NO : 214 937 2000   
3451 PLANO PARKWAY                SE DECISION MADE: 24-MAY-11
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARSTASIS DILATOR ADAPTER
ARSTASIS, INC.                    510(k) NO: K103421(TRADITIONAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 508 1549   
1021 HOWARD AVE SUITE C           SE DECISION MADE: 24-MAY-11
SAN CARLOS CA 94070               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFEBRIDGE
LIFEBRIDGE MEDIZINTECHNIK AG      510(k) NO: K111384(SPECIAL)
ATTN: KATHLEEN  JOHNSON           PHONE NO : 641 472 0775   
P.O. BOX 2042                     SE DECISION MADE: 24-MAY-11
FAIRFIELD IA 52556                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBW NM 2.0
PHILIPS  MEDICAL SYSTEMS (CLEVELAN510(k) NO: K111336(TRADITIONAL)
ATTN: LORI R PETERSON             PHONE NO : 408 468 3042   
3860 N. First Street              SE DECISION MADE: 24-MAY-11
San Jose CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SMART LEISH, MODEL LGM1-050
U.S. ARMY MEDICAL RESEARCH INSTITU510(k) NO: K081868(TRADITIONAL)
ATTN: ROBER  MILLER               PHONE NO : 301 619 0317   
1452 PORTER STREET                SE DECISION MADE: 25-MAY-11
FORT DETRICK MD 21702 9232        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX BARITURATES ASSAY
RANDOX LABORATORIES, LTD.         510(k) NO: K092268(TRADITIONAL)
ATTN: P  ARMSTRONG                PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 25-MAY-11
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) STATEMENT

DEVICE: SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
SURGIQUEST, INC.                  510(k) NO: K103692(TRADITIONAL)
ATTN: DANIEL  DONOVAN             PHONE NO : 203 799 2400   
12 CASCADE BLVD. SUITE 2B         SE DECISION MADE: 25-MAY-11
ORANGE CT 06477                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABG II MONOLITHIC HIP STEM
STRYKER CORP.                     510(k) NO: K110807(TRADITIONAL)
ATTN: STEPHANIE  FITTS            PHONE NO : 201 831 5405   
325 CORPORATE DRIVE               SE DECISION MADE: 25-MAY-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLASSIX CHEMICAL STERILIZATION INDICATOR
PROPPER MFG. CO., INC.            510(k) NO: K102894(ABBREVIATED)
ATTN: ANDREW  SHARAVARA           PHONE NO : 800 832 4300   
36-04 SKILLMAN AVE.               SE DECISION MADE: 25-MAY-11
LONG ISLAND CITY NY 11101         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCHRON MULTI CALIBRATOR
BECKMAN COULTER, INC.             510(k) NO: K110251(TRADITIONAL)
ATTN: YVETTE  LLOYD               PHONE NO : 714 961 3626   
250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 25-MAY-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEUCADIA PEDICLE SCREW SYSTEM
PHYGEN, LLC                       510(k) NO: K110588(TRADITIONAL)
ATTN: HARTMUT  LOCH               PHONE NO : 949 752 7885   
2301 DUPONT DRIVE SUITE 510       SE DECISION MADE: 25-MAY-11
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K110132(TRADITIONAL)
ATTN: KRISTIN  PABST              PHONE NO : 414 721 3104   
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 25-MAY-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SPINE SYSTEM
CORELINK, LLC                     510(k) NO: K110321(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
101 OAKWOOD BLVD                  SE DECISION MADE: 25-MAY-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJINON DIGITAL VIDEO PROCESSOR
FUJINON, INC.                     510(k) NO: K102466(TRADITIONAL)
ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 25-MAY-11
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO-V COAT
BISCO, INC.                       510(k) NO: K103514(TRADITIONAL)
ATTN: MICHELLE  SCHILTZ-TAING     PHONE NO : 847 534 6146   
1100 WEST IRVING PARK RD.         SE DECISION MADE: 25-MAY-11
SCHAUMBURG IL 60193               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NANOTACK SUTURE ANCHOR 1.4MM
PIVOT MEDICAL                     510(k) NO: K110473(TRADITIONAL)
ATTN: JON  COOK                   PHONE NO : 408 774 1452   
247 HUMBOLDT CT.                  SE DECISION MADE: 25-MAY-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL STIMULATORS
TECHNOMED EUROPE                  510(k) NO: K110422(TRADITIONAL)
ATTN: PIERRE  VREULS              PHONE NO : 310 434 086868
AMERIKALAAN 71                    SE DECISION MADE: 26-MAY-11
MAASTRICHT AIRPORT    NL 6199 AE  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELL-CHEX WITH CPPD CRYSTALS
STRECK                            510(k) NO: K110718(TRADITIONAL)
ATTN: DEBORAH  KIPP               PHONE NO : 402 537 5215   
7002 SOUTH 109TH ST.              SE DECISION MADE: 26-MAY-11
OMAHA NE 68128                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFX INTRODUCER SYSTEM
ENDOLOGIX, INC.                   510(k) NO: K110090(TRADITIONAL)
ATTN: JANET M FAULS               PHONE NO : 949 595 7203   
11 STUDEBAKER                     SE DECISION MADE: 26-MAY-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICURE CRYO MODULE
ATRICURE, INC.                    510(k) NO: K111042(TRADITIONAL)
ATTN: REBECCA  WALTERS            PHONE NO : 513 755 4576   
6217 CENTRE PARK DRIVE            SE DECISION MADE: 26-MAY-11
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: E3 TORQUE CONTROL MOTOR
DENTSPLY INTERNATIONAL INC.       510(k) NO: K103653(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 845 7511   
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 26-MAY-11
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
FILLIGENT LIMITED                 510(k) NO: K101128(TRADITIONAL)
ATTN: IAN  GORDON                 PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 26-MAY-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYFRA 21-1 EIA MODEL 211-10
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K100831(TRADITIONAL)
ATTN: STACEY  DOLAN               PHONE NO : 610 240 3843   
201 GREAT VALLEY PARKWAY          SE DECISION MADE: 26-MAY-11
MALVERN PA 19355 1307             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDAX UNIPERSONALE SRL
MEDAX UNIPERSONALE SRL            510(k) NO: K092338(TRADITIONAL)
ATTN: FLAVIO  TOMASSINI           PHONE NO : 305 594 8565   
3016 N.W. 82ND AVE.               SE DECISION MADE: 27-MAY-11
MIAMI FL 33122                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K101681(ABBREVIATED)
ATTN: LEO  WANG                   PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 27-MAY-11
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
DIPPED PRODUCTS LIMITED           510(k) NO: K100895(TRADITIONAL)
ATTN: W.S.E.F.  FERNANDO          PHONE NO : 941 126 83964
400 DEANS ROAD                    SE DECISION MADE: 27-MAY-11
COLUMBO    CE 10                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
PHADIA AB                         510(k) NO: K101251(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVENUE            SE DECISION MADE: 27-MAY-11
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KONIX ULTRASOUND GEL
TURKUAZ SAGLIK HIZMETLERI MEDIKAL 510(k) NO: K101952(TRADITIONAL)
ATTN: MICHAEL  SCOTT              PHONE NO : 775 586 8700   
88 MCFAUL WAY P.O. BOX 10321      SE DECISION MADE: 27-MAY-11
ZEPHYR COVE NV 89448              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIRECTVISION CATHETER, UNCOATED
PERCUVISION                       510(k) NO: K110214(SPECIAL)
ATTN: FIDES  MALDONADO            PHONE NO : 508 231 8842   
200 HOMER AVE, 2ND FLOOR          SE DECISION MADE: 27-MAY-11
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC.      510(k) NO: K110226(SPECIAL)
ATTN: SURESH  GHAI                PHONE NO : 952 912 5400   
5909 BAKER ROAD SUITE 550         SE DECISION MADE: 27-MAY-11
MINNETONKA MN 55345               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILJETR SYSTEM
DANVILLE MATERIALS INC.           510(k) NO: K110642(TRADITIONAL)
ATTN: LINDSAY  TILTON             PHONE NO : 925 973 0710   
3420 FOSTORIA WAY ST. A-200       SE DECISION MADE: 27-MAY-11
SAN RAMON CA 94583                510(k) STATEMENT

DEVICE: 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
ARTHROCARE CORP.                  510(k) NO: K110781(SPECIAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224   
680 VAQUEROS AVE.                 SE DECISION MADE: 27-MAY-11
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHOINSIGHT
ULTRASOUND MEDICAL DEVICES, INC.  510(k) NO: K110447(TRADITIONAL)
ATTN: PAUL  KORTESOJA             PHONE NO : 734 369 5100   
3917 RESEARCH PARK DRIVE SUITE B7 SE DECISION MADE: 27-MAY-11
ANN ARBOR MI 48108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC.                   510(k) NO: K110097(SPECIAL)
ATTN: KERI  YEN                   PHONE NO : 650 687 5874   
1525-B O'BRIEN DR.                SE DECISION MADE: 27-MAY-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIMARA
VOCO GMBH                         510(k) NO: K110589(TRADITIONAL)
ATTN: MANFRED T PLAUMANN          PHONE NO : 494 721 7190
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 27-MAY-11
CUXHAVEN    GM 27472              510(k) STATEMENT

DEVICE: 4CH FLEX SPEEDER
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K111251(SPECIAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 27-MAY-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
FUJIREBIO DIAGNOSTICS, INC        510(k) NO: K110641(TRADITIONAL)
ATTN: JOHN  GORMLEY               PHONE NO : 800 531 7963   
940 CROSSROADS BLVD.              SE DECISION MADE: 27-MAY-11
SEGUIN TX 78155                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
IMAGING DYNAMICS COMPANY LTD.     510(k) NO: K111098(SPECIAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 27-MAY-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K110785(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DR                  SE DECISION MADE: 27-MAY-11
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK REVISION HYBRID LINERS
MEDACTA INTERNATIONAL             510(k) NO: K111283(SPECIAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 437 7085   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 27-MAY-11
CAMARILLO CA 91302                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
KINGTECH ENTERPRISE, LTD.         510(k) NO: K102935(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
FARM VILLAGE DALINGSHAN TOWN      SE DECISION MADE: 27-MAY-11
DONGUAN    CH                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEAK SUCTION COAGULATOR
PEAK SURGICAL, INC.               510(k) NO: K103775(TRADITIONAL)
ATTN: LOIS  NAKAYAMA              PHONE NO : 650 331 8920   
2464 EMBARCADERO WAY              SE DECISION MADE: 27-MAY-11
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE IC-PRO SYSTEM
PAIEON, INC.                      510(k) NO: K110256(TRADITIONAL)
ATTN: EREZ  BEN-ZVI               PHONE NO : 972 391 50000
23 HAMELACHA ST., P.O.B. 11355    SE DECISION MADE: 27-MAY-11
ROSH HAAYIN    IS 48901           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
SKANRAY TECHNOLOGIES              510(k) NO: K111330(TRADITIONAL)
ATTN: PARASURAMAPPA  BELUR        PHONE NO : 918 212 415559
PLOT 15-17 HEBBAL INDUSTRIAL AREA SE DECISION MADE: 27-MAY-11
MYSORE    IN 570016               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HAIRMAX LASERCOMB
LEXINGTON INTERNATIONAL, LLC      510(k) NO: K110233(TRADITIONAL)
ATTN: CASPER E ULDRIKS ESQ.       PHONE NO : 202 518 6385   
1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 27-MAY-11
WASHINGTON DC 20036               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K102049(SPECIAL)
ATTN: TELING  HSU                 PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 27-MAY-11
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M4 MONITOR
SOPECTRUM MEDICAL LLP             510(k) NO: K110957(TRADITIONAL)
ATTN: STEVE  TURNER               PHONE NO : 440 124 2650121
HARRIER 4, METEOR BUSINESS PK CHELSE DECISION MADE: 31-MAY-11
GLOUCESTER    UK GL2 9QL          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K111295(SPECIAL)
ATTN: MARK  MURPHY                PHONE NO : 763 494 2377   
ONE SCIMED PLACE                  SE DECISION MADE: 31-MAY-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORCETRIAD ELECTROSURGICAL GENERATOR
COVIDIEN LP, FORMERLY KNOW AS VALL510(k) NO: K110268(TRADITIONAL)
ATTN: DONALD  HENTON              PHONE NO : 303 530 6451   
5920 LONGBOW DR.                  SE DECISION MADE: 31-MAY-11
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   252                                     
                                                 TOTAL WITH SUMMARIES        234                                     
                                                 TOTAL WITH STATEMENTS        18