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U.S. Department of Health and Human Services

Medical Devices

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February 2011 510(k) Clearances

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



DEVICE: VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
CARL ZEISS MEDITEC AG             510(k) NO: K103056(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE         PHONE NO : 925 557 4616
5160 HACIENDA DRIVE               SE DECISION MADE: 01-FEB-11
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
TELEFLEX MEDICAL, INC.            510(k) NO: K102238(SPECIAL)
ATTN: SUZANNE  SCHORLE            PHONE NO : 610 378 0131
2400 BERNVILLE ROAD               SE DECISION MADE: 01-FEB-11
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
INTERVASCULAR, SAS                510(k) NO: K103347(SPECIAL)
ATTN: PHILIPPE  BENSIMON          PHONE NO : 334 420 87784
ZONE INDUSTRIELLE ATHELIA I       SE DECISION MADE: 02-FEB-11
LACIOTAT    FR 13705              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPO CLENZ WOUND WASH MODEL 100 PPM
NEVOA LIFE SCIENCES, LLC          510(k) NO: K100948(TRADITIONAL)
ATTN: S. DAVID  PIPER, PE         PHONE NO : 916 483 3687
4807 EL CAMINO AVE SUITE C        SE DECISION MADE: 02-FEB-11
CARMICHAEL CA 95608               510(k) STATEMENT

DEVICE: SURGIAID
MAXIGEN BIOTECH, INC.             510(k) NO: K100927(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 773 6340
2904 N BOLDT AVE                  SE DECISION MADE: 02-FEB-11
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PET-512MC TRANSESOPHAGEAL TRANSDUCER
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K103629(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000
2441 MICHELLE DR. P.O. BOX 2068   SE DECISION MADE: 02-FEB-11
TUSTIN CA 92781 2068              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAIRE COMPRESSION SYSTEM
VENOUS HEALTH SYSTEMS, INC.       510(k) NO: K103113(TRADITIONAL)
ATTN: ALBERT  BONISKE             PHONE NO : 408 400 0856
155-A MOFFETT PARK DRIVE SUITE #21SE DECISION MADE: 02-FEB-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SECURVIEW DX DIAGNOSTIC WORKSTATION
HOLOGIC, INC.                     510(k) NO: K103385(SPECIAL)
ATTN: GAIL  YAEKER-DAUNIS         PHONE NO : 203 731 8337
37 APPLE RIDGE ROAD               SE DECISION MADE: 02-FEB-11
DANBURY CT 06810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
ACON LABORATORIES, INC.           510(k) NO: K103387(TRADITIONAL)
ATTN: RICHARD  LENART             PHONE NO : 858 875 8019
10125 MESA RIM RD.                SE DECISION MADE: 02-FEB-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K103143(SPECIAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 508 1549
1021 HOWARD AVE SUITE C           SE DECISION MADE: 02-FEB-11
SAN CARLOS CA 94070               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
COOK, INC.                        510(k) NO: K110009(SPECIAL)
ATTN: KAREN  BRADBURN             PHONE NO : 812 339 2235
750 DANIELS WAY P.O. BOX 489      SE DECISION MADE: 02-FEB-11
BLOOMINGTON IN 47402              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESS ENDOSCOPE STERILIZATION TRAY
ENTELLUS MEDICAL, INC.            510(k) NO: K103213(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 02-FEB-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PEDIACYN ATOPIC DERMATITIS HYDROGEL
OCULUS INNOVATIVE SCIENCES, INC.  510(k) NO: K102945(TRADITIONAL)
ATTN: ANTOINETTE  DOUGLAS         PHONE NO : 707 559 2445
1135 N. MC DOWELL BLVD            SE DECISION MADE: 02-FEB-11
PETALUMA CA 94954                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNATURE PLANNER; SIGNATURE GUIDES
MATERIALISE N.V.                  510(k) NO: K102795(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 32 16 396280
TECHNOLOGIELAAN 15                SE DECISION MADE: 02-FEB-11
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE                      510(k) NO: K103393(SPECIAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300
100 INTERPACE PARKWAY             SE DECISION MADE: 02-FEB-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTICARE SAFETY INSULIN SYRINGE
ULTI-MED INTL., INC.              510(k) NO: K103011(TRADITIONAL)
ATTN: MARY BETH  HENDERSON        PHONE NO : 952 227 3380
5353 WAYZATA BOULEVARD SUITE 505  SE DECISION MADE: 02-FEB-11
MINNEAPOLIS MN 55416              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NASAL CEASE
CATALINA, INC.                    510(k) NO: K102742(TRADITIONAL)
ATTN: RICHARD J FREER             PHONE NO : 804 285 7034
8110 WESTBURY DR.                 SE DECISION MADE: 02-FEB-11
RICHMOND VA 23229                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
SILMET LTD.                       510(k) NO: K103190(TRADITIONAL)
ATTN: MOSHE  ZALSMAN              PHONE NO : 972 353 31474
12 HASADNA                        SE DECISION MADE: 02-FEB-11
OR YEHUDA    IS 60200             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
IMRIS, INC.                       510(k) NO: K103506(TRADITIONAL)
ATTN: THOMAS M TASKERIS           PHONE NO : 301 330 2076
16809 BRIARDALE ROAD              SE DECISION MADE: 02-FEB-11
ROCKVILLE MD 20855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TALON SPINAL SYSTEM
SPINE360                          510(k) NO: K102995(SPECIAL)
ATTN: DAVE  LAMB                  PHONE NO : 512 327 6403
5000 PLAZA ON THE LAKE SUITE 305  SE DECISION MADE: 02-FEB-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K070049(TRADITIONAL)
ATTN: JANET C KAY                 PHONE NO : 781 699 4475
920 WINTER ST.                    SE DECISION MADE: 03-FEB-11
WALTHAM MA 02451 1457             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONICA AN24
MONICA HEALTHCARE                 510(k) NO: K101801(TRADITIONAL)
ATTN: IAN  HOW                    PHONE NO : 44 115 9124541
PENNYFOOT STREET                  SE DECISION MADE: 03-FEB-11
NOTTINGHAM    UK NG1 1GF          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
GRI MEDICAL & ELECTRONIC TECHNOLOG510(k) NO: K102652(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978
717 LAKEGLEN DRIVE                SE DECISION MADE: 03-FEB-11
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUTRAZORB
VISIONARY MEDICAL SUPPLIES, INC.  510(k) NO: K102592(ABBREVIATED)
ATTN: GARY  SYRING                PHONE NO : 608 877 2635
800 LEVANGER LN.                  SE DECISION MADE: 03-FEB-11
STOUGHTON WI 53589                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BALL ABUTMENT SYSTEM
MEGAGEN CO., LTD.                 510(k) NO: K101890(TRADITIONAL)
ATTN: JOYCE  BANG                 PHONE NO : 714 525 0114
325 N. PUENTE STREET UNIT B       SE DECISION MADE: 03-FEB-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BUTLER CALCI-FLOR PROPHYLAXIS PASTE
SUNSTAR AMERICAS, INC.            510(k) NO: K102053(TRADITIONAL)
ATTN: CARL  JENKINS               PHONE NO : 847 234 7500
10 E. SCANTON AVE SUITE 201       SE DECISION MADE: 03-FEB-11
LAKE BLUFF IL 60044               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT EXAMINATION GLOVES
THAI HUA HOLDING CO., LTD.        510(k) NO: K102838(TRADITIONAL)
ATTN: KOK-KEE  HON                PHONE NO : 703 941 7656
6324 MEETINGHOUSE WAY             SE DECISION MADE: 03-FEB-11
ALEXANDRIA VA 22312 1718          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
MENICON CO. LTD.                  510(k) NO: K103561(TRADITIONAL)
ATTN: BEVERLEY D VENUTI           PHONE NO : 978 658 6888
187 BALLARDVALE STREET SUITE 180  SE DECISION MADE: 03-FEB-11
WILMINGTON MA 01887               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
SMITH & NEPHEW ENDOSCOPY, INC.    510(k) NO: K103309(TRADITIONAL)
ATTN: KATHLEEN  SOLOMON           PHONE NO : 978 749 1605
150 MINUTEMAN ROAD                SE DECISION MADE: 03-FEB-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
AQUA SCIENCES, INC.               510(k) NO: K102892(TRADITIONAL)
ATTN: MICHAEL J TODD              PHONE NO : 716 695 1200
565 FILLMORE AVENUE               SE DECISION MADE: 03-FEB-11
TONAWANDA NY 14150                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
ATLANTIS COMPONENTS, INC.         510(k) NO: K103020(TRADITIONAL)
ATTN: BETSY  BROWN                PHONE NO : 847 560 4406
8944 TAMAROA TERRACE              SE DECISION MADE: 03-FEB-11
SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
HOWMEDICA OSTEONICS CORP          510(k) NO: K103233(TRADITIONAL)
ATTN: AVITAL  MERL-MARGULIES      PHONE NO : 201 831 6365
325 CORPORATE DR.                 SE DECISION MADE: 03-FEB-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
VERTICAL TECHNOLOGY, INC.         510(k) NO: K110045(SPECIAL)
ATTN: SURESH  GHAI                PHONE NO : 952 979 9357
5909 BAKER ROAD, SUITE 550        SE DECISION MADE: 03-FEB-11
MINNESOTA MN 55345                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBO TEMP 3
DANVILLE MATERIALS, INC.          510(k) NO: K102753(TRADITIONAL)
ATTN: LINDSAY  TILTON             PHONE NO : 925 973 0710
3420 FOSTORIA WAY, SUITE A-200    SE DECISION MADE: 04-FEB-11
SAN RAMON CA 94583                510(k) STATEMENT

DEVICE: BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
BAM CORP., LTD.                   510(k) NO: K093835(ABBREVIATED)
ATTN: MARY  MEJAES                PHONE NO : 852 231 41300
UNIT 1706, TOWER 2, GRAND CNTL PLASE DECISION MADE: 04-FEB-11
COMMITTEE RD.,SHATIN, N.T.    HK  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GOLDEN GATE ANTERIOR PLATE SYSTEM
ULRICH GMBH & CO. KG              510(k) NO: K101353(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268
754 SPIRIT 40 PARK DRIVE          SE DECISION MADE: 04-FEB-11
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVUE COLORMARK9TM) NEEDLE
NU VUE THERAPEUTICS, INC          510(k) NO: K101312(TRADITIONAL)
ATTN: ROGER S KOLASINSKI          PHONE NO : 703 591 1691
11135 SEDGEFIELD ROAD             SE DECISION MADE: 04-FEB-11
FAIRFAX VA 22030                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
ASTORIA-PACIFIC,INC.              510(k) NO: K101392(TRADITIONAL)
ATTN: JASON C REYNOLDS            PHONE NO : 503 657 3010
15130 S.E. 82ND DR.               SE DECISION MADE: 04-FEB-11
CLACKAMAS OR 97015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
INTUITIVE SURGICAL, INC.          510(k) NO: K101077(TRADITIONAL)
ATTN: KAREN  UYESUGI              PHONE NO : 408 523 2100
950 KIFER RD.                     SE DECISION MADE: 04-FEB-11
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEREOS WORKSTATION
BIOSPACE MED                      510(k) NO: K101398(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638
555 THIRTEENTH ST. NW             SE DECISION MADE: 04-FEB-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETAL DOPPLER JPD-100S
SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K110124(TRADITIONAL)
ATTN: DIANE  HONG                 PHONE NO : 862 164 264467
P.O. BOX 237-023                  SE DECISION MADE: 04-FEB-11
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: COHESION BONE CEMENT
TEKNIMED, S.A.S.                  510(k) NO: K103816(SPECIAL)
ATTN: J. D WEBB                   PHONE NO : 512 388 0199
1001 OAKWOOD BLVD                 SE DECISION MADE: 04-FEB-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
INOVISE MEDICAL, INC.             510(k) NO: K103516(TRADITIONAL)
ATTN: EARL  ANDERSON              PHONE NO : 503 431 3821
8770 SW NIMBUS AVENUE SUITE D     SE DECISION MADE: 04-FEB-11
BEAVERTON OR 97008 7196           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICONSTITUENT CALIBRATOR
ABBOT LABORATORIES                510(k) NO: K103403(TRADITIONAL)
ATTN: LINDA  MORRIS               PHONE NO : 972 518 6711
1921 HURD DRIVE                   SE DECISION MADE: 04-FEB-11
IRVING TX 75038 4396              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
SPACELABS HEALTHCARE LTD.         510(k) NO: K103732(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232
PO BOX 3018                       SE DECISION MADE: 04-FEB-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
INTUITIVE SURGICAL, INC.          510(k) NO: K101743(TRADITIONAL)
ATTN: KAREN  UYESUGI              PHONE NO : 408 523 2100
950 KIFER RD.                     SE DECISION MADE: 04-FEB-11
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K110104(TRADITIONAL)
ATTN: STEVEN J BERKE              PHONE NO : 513 772 8810
12011 MOSTELLER RD.               SE DECISION MADE: 04-FEB-11
CINCINNATI OH 45241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
VECTEC                            510(k) NO: K103707(TRADITIONAL)
ATTN: DIANE MANDELL  HORWITZ      PHONE NO : 703 307 2921
2995 STEVEN MARTIN DR.            SE DECISION MADE: 04-FEB-11
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILE MIM
MIM SOFTWARE INC.                 510(k) NO: K103785(TRADITIONAL)
ATTN: LYNN  HANIGAN               PHONE NO : 216 455 0600
25200 Chagrin Blvd. Suite 200     SE DECISION MADE: 04-FEB-11
Cleveland OH 44122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MH1 MICROHOLTER RECORDER
EXELYS LLC                        510(k) NO: K101969(TRADITIONAL)
ATTN: NEAL  KOLBER                PHONE NO : 512 327 9997
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 04-FEB-11
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACIES
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K101842(TRADITIONAL)
ATTN: RUSSELL  MUNVES             PHONE NO : 212 497 8208
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 04-FEB-11
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
TECO DIAGNOSTICS                  510(k) NO: K101673(TRADITIONAL)
ATTN: KC  CHEN                    PHONE NO : 714 163 1111
1268 NORTH LAKEVIEW AVE.          SE DECISION MADE: 04-FEB-11
ANAHEIM CA 92807                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
BODYSTAT LTD.                     510(k) NO: K082255(TRADITIONAL)
ATTN: I J.  MEEUWSEN              PHONE NO : 446 246 29571
PO BOX 50 DOUGLAS ISLE OF MAN     SE DECISION MADE: 07-FEB-11
BRITISH ISLES    UK IM99 1DQ      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
CODONICS, INC.                    510(k) NO: K101439(TRADITIONAL)
ATTN: GARY W ENOS                 PHONE NO : 440 243 1198
17991 ENGLEWOOD DR.               SE DECISION MADE: 07-FEB-11
MIDDLEBURG HEIGHTS OH 44130       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIOPATCH
IZUN PHARMACEUTICALS CORPORATION  510(k) NO: K103054(TRADITIONAL)
ATTN: IRVING  WIESEN              PHONE NO : 212 381 8774
420 LEXINGTON AVENUE              SE DECISION MADE: 07-FEB-11
NEW YORK NY 10170                 510(k) STATEMENT

DEVICE: COROENT INTERLOCK SYSTEM
NUVASIVE, INC.                    510(k) NO: K102547(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515
7475 LUSK BLVD                    SE DECISION MADE: 07-FEB-11
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
BECKMAN COULTER, INC.             510(k) NO: K103373(TRADITIONAL)
ATTN: YVETTE  LLOYD               PHONE NO : 714 961 3626
250 S. KRAEMER BOULEVARD          SE DECISION MADE: 07-FEB-11
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
ANGSTROM MFG., INC.               510(k) NO: K103158(TRADITIONAL)
ATTN: CHRIS  CARRON               PHONE NO : 573 483 3773
6539 U.S. HWY. 61                 SE DECISION MADE: 07-FEB-11
BLOOMSDALE MO 63627               510(k) STATEMENT

DEVICE: MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
BODYSTAT LTD.                     510(k) NO: K082254(TRADITIONAL)
ATTN: I. J.  MEEUWSEN             PHONE NO : 446 246 29571
PO BOX 50 DOUGLAS ISLE OF MAN     SE DECISION MADE: 07-FEB-11
BRITISH ISLES    UK IM99 1DQ      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITOSS BA BOOST BIOACTIVE BONE GRAFT SUBSTITUTE
ORTHOVITA, INC.                   510(k) NO: K103173(SPECIAL)
ATTN: DEBORAH L JACKSON           PHONE NO : 610 407 5210
45 GREAT VALLEY PKWY.             SE DECISION MADE: 07-FEB-11
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
COVIDIEN, FORMERLY VALLEYLAB,     510(k) NO: K102470(TRADITIONAL)
ATTN: DAVID M HORTON              PHONE NO : 303 530 6391
5920 LONGBOW DRIVE                SE DECISION MADE: 07-FEB-11
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDEOR MATRIX
KENSEY NASH CORP.                 510(k) NO: K103787(TRADITIONAL)
ATTN: LORI  BURNS                 PHONE NO : 484 713 2186
735 PENNSYLVANIA DRIVE            SE DECISION MADE: 07-FEB-11
EXTON PA 19341                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
MICERIUM S.P.A.                   510(k) NO: K103474(TRADITIONAL)
ATTN: SSA CARLA  TAZZER           PHONE NO : 39 01 857887840
VIA MARCONI 83                    SE DECISION MADE: 07-FEB-11
AVENGO    IT 16030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
HAKKI MEDICAL TECHNOLOGIES, INC.  510(k) NO: K101900(TRADITIONAL)
ATTN: ANDREW  ENDAHL              PHONE NO : 407 493 6806
3851 62ND AVE. NORTH SUITE A      SE DECISION MADE: 07-FEB-11
PINELLAS PARK FL 33781            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
ILUMARK GMBH                      510(k) NO: K103192(TRADITIONAL)
ATTN: ANDRE  WEINGERL             PHONE NO : 497 463 995413
GRIESWEG 47                       SE DECISION MADE: 07-FEB-11
MUHLHEIM    GM 78570              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
ARTHROCARE CORP.                  510(k) NO: K110164(SPECIAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224
680 VAQUEROS AVE.                 SE DECISION MADE: 07-FEB-11
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
VIBRYNT, INC                      510(k) NO: K100533(TRADITIONAL)
ATTN: JULIA S ANASTAS             PHONE NO : 650 362 6136
701-A GALVESTON DRIVE             SE DECISION MADE: 08-FEB-11
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
GE HEALTHCARE                     510(k) NO: K101236(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214
9900 INNOVATION DRIVE             SE DECISION MADE: 08-FEB-11
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEL HEALTH GUIDE
INTEL CORPORATION DIGITAL HEALTH G510(k) NO: K103276(ABBREVIATED)
ATTN: MAUREEN  GYLNN              PHONE NO : 916 356 1109
1900 PRAIRIE CITY ROAD FM7-197    SE DECISION MADE: 08-FEB-11
Folsom CA 95630                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K110202(TRADITIONAL)
ATTN: KATHERINE Y CHOI            PHONE NO : 203 602 3568
419 WEST AVE.                     SE DECISION MADE: 08-FEB-11
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DEFIBRILLATOR ANALYZER - DA-2006P
BC GROUP INTERNATIONAL, INC       510(k) NO: K110192(TRADITIONAL)
ATTN: JACK  SLOVICK               PHONE NO : 763 639 0238
2913 209TH LANE NW                SE DECISION MADE: 08-FEB-11
OAK GROVE MN 55011                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K110199(TRADITIONAL)
ATTN: ZHAI  PEI                   PHONE NO : 867 552 6582888
MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 08-FEB-11
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
LEONHARD LANG GMBH                510(k) NO: K103186(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035
P.O. BOX 560                      SE DECISION MADE: 08-FEB-11
STILLWATER MN 55082 0560          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWREST
VAPOTHERM, INC.                   510(k) NO: K103316(TRADITIONAL)
ATTN: GREGORY A WHITNEY           PHONE NO : 410 604 0808
198 LOG CANOE CIRCLE              SE DECISION MADE: 08-FEB-11
STEVENSVILLE MD 21666             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
JEIL MEDICAL CORPORATION          510(k) NO: K101902(TRADITIONAL)
ATTN: CATHY  CAMBRIA              PHONE NO : 770 396 5909
1733 CANTON LANE                  SE DECISION MADE: 08-FEB-11
MARIETTA GA 30062                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED-LOK SAFETY NEEDLE
STA-MED, LLC                      510(k) NO: K103781(SPECIAL)
ATTN: RANDALL  MAY                PHONE NO : 949 209 8969
4932 E. HOLBROOK STREET           SE DECISION MADE: 08-FEB-11
ANAHEIM CA 92807                  510(k) STATEMENT

DEVICE: TRILLIANT SURGICAL SUBTALAR IMPLANT
TRILLIANT SURGICAL LTD            510(k) NO: K103183(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199
1001 OAKWOOD BLVD                 SE DECISION MADE: 08-FEB-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICAL VISORS MV100
MEDICAL VISORS, INC               510(k) NO: K103507(TRADITIONAL)
ATTN: BRAIN  HUGHES               PHONE NO : 818 961 4622
3834 ORCHID LANE SUITE B          SE DECISION MADE: 08-FEB-11
CALABASAS CA 91302                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEAL FORCE CO2 INCUBATOR
SHANGHAI LISHEN SCIENTIFIC EQUIPME510(k) NO: K101988(TRADITIONAL)
ATTN: CHARLES  MACK               PHONE NO : 541 376 5063
77325 JOYCE WAY                   SE DECISION MADE: 08-FEB-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
SMITH & NEPHEW, INC.              510(k) NO: K110069(SPECIAL)
ATTN: SHEREEN  MYERS              PHONE NO : 901 399 6325
1450 EAST BROOKS RD.              SE DECISION MADE: 08-FEB-11
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEUCADIA PEDICLE SCREW SYSTEM
PHYGEN, LLC                       510(k) NO: K103102(SPECIAL)
ATTN: HARTMUT  LOCH               PHONE NO : 949 752 7885
2301 DUPONT DRIVE SUITE 510       SE DECISION MADE: 08-FEB-11
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
LANX, LLC                         510(k) NO: K103040(SPECIAL)
ATTN: DAMON  BELLONI              PHONE NO : 303 443 7500
390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 08-FEB-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-STAT 1 WIRELESS ANALYZER
ABBOTT POINT OF CARE INC.         510(k) NO: K103195(TRADITIONAL)
ATTN: LARRY W KRASLEY             PHONE NO : 609 454 9000
400 COLLEGE RD EAST               SE DECISION MADE: 08-FEB-11
PRINCETON NJ 08540                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSE OXIMETER MODEL P10
MEDIANA CO., LTD.                 510(k) NO: K100225(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063
77325 JOYCE WAY                   SE DECISION MADE: 09-FEB-11
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSE PLIF CAFE
ADVANCED MEDICAL TECHNOLOGIES AG  510(k) NO: K100945(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199
1001 OAKWOOD BLVD.                SE DECISION MADE: 09-FEB-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYONIZE TM
3JT ENTERPRISES LLC               510(k) NO: K103310(TRADITIONAL)
ATTN: ANTHONY  GOLDBOSS           PHONE NO : 312 952 5462
2000 N. RACINE AVE SUITE 3100     SE DECISION MADE: 09-FEB-11
CHICAGO IL 60614                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMMERLOC TM TIBIAL FIXATION DEVICE
BIOMET SPORTS MEDICINE            510(k) NO: K103145(TRADITIONAL)
ATTN: ROBERT  FRIDDLE             PHONE NO : 574 267 6639
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 09-FEB-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
BLACKROCK MICROSYSTEMS, INC       510(k) NO: K110010(SPECIAL)
ATTN: JERRY  ALPERIN              PHONE NO : 801 582 5533
391 CHIPETA WAY SUITE G           SE DECISION MADE: 09-FEB-11
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAIO-7, AAIO WIRLESS
APPASAMY ASSOCIATES               510(k) NO: K110205(TRADITIONAL)
ATTN: K  RENGASAMY                PHONE NO : 910 443 2980153
20, SBI OFFICERS COLONY 1ST STREETSE DECISION MADE: 09-FEB-11
ARUMBAKKAM, CHENNAI    IN 600 106 510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: EXPLORER LIVER (PASSIVE TRACKING)
PATHFINDER THERAPEUTICS, INC.     510(k) NO: K101979(SPECIAL)
ATTN: SENHU  LI                   PHONE NO : 615 783 0094
2969 ARMORY DR. SUITE 100A        SE DECISION MADE: 09-FEB-11
NASHVILLE TN 37204                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
STERIS CORPORATION                510(k) NO: K102296(TRADITIONAL)
ATTN: ROBERT  SULLIVAN            PHONE NO : 440 392 7695
5960 HEISLEY ROAD                 SE DECISION MADE: 09-FEB-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENUS BASIC SPINAL FIXATION SYSTEM
L&K BIOMED CO., LTD               510(k) NO: K103085(SPECIAL)
ATTN: HEE KYEONG  JOO             PHONE NO : 822 262 41471
#1104, ACE HIGH-END TOWER 2CHA, 37SE DECISION MADE: 09-FEB-11
GEUMCHEON-GU, SEOUL    KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
ESWALLOW USA                      510(k) NO: K092202(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735
8870 RAVELLO COURT                SE DECISION MADE: 10-FEB-11
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLONRING
NITI SURGICAL SOLUTIONS LTD       510(k) NO: K093661(TRADITIONAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794
555 THIRTEENTH STREET, NW         SE DECISION MADE: 10-FEB-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
EXCELSIOR MEDICAL CORP.           510(k) NO: K101270(TRADITIONAL)
ATTN: NANCY  RUTH                 PHONE NO : 905 689 3980
4 INNOVATION DRIVE                SE DECISION MADE: 10-FEB-11
DUNDAS, ON    CA L2H 7P3          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REUSABLE LINEAR STAPLER HANDLE
ETHICON ENDO-SURGERY, LLC         510(k) NO: K110049(TRADITIONAL)
ATTN: DENNIS  HAHN                PHONE NO : 513 337 3134
4545 CREEK ROAD                   SE DECISION MADE: 10-FEB-11
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REDSENSE-ALARM UNIT AND SENSOR
REDSENSE MEDICAL AB               510(k) NO: K103242(TRADITIONAL)
ATTN: CONSTANCE G BUNDY           PHONE NO : 763 574 1976
435 RICE CREEK TERRANCE           SE DECISION MADE: 10-FEB-11
FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPPHINE PLUS STM 3W DIODE LASER
DEN-MAT HOLDINGS, LLC             510(k) NO: K110079(TRADITIONAL)
ATTN: ALAN B METTHEWS             PHONE NO : 805 922 8491
2727 SKYWAY DR.                   SE DECISION MADE: 10-FEB-11
SANTA MARIA CA 93455              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VENUS ANTERIOR CERVICAL PLATE
VERTICOR, LTD                     510(k) NO: K103137(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 399 0199
1001 OAKWOOD BLVD.                SE DECISION MADE: 10-FEB-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENOFER PUMP
RENAL SOLUTIONS, INC.             510(k) NO: K103564(SPECIAL)
ATTN: DAVID  VANELLA              PHONE NO : 724 772 6900
770 COMMONWEALTH DR SUITE 101     SE DECISION MADE: 10-FEB-11
WARRENDALE PA 15086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEUS SCIENTIFIC, INC.  TREPONEMA PALLIDUM IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC.             510(k) NO: K102283(TRADITIONAL)
ATTN: EWA  NADOLCZAK              PHONE NO : 908 526 3744
200 EVANS WAY                     SE DECISION MADE: 10-FEB-11
BRANCHBURG NJ 08876               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSORIA-LIGHT
PSORIA-SHIELD INC.                510(k) NO: K103540(TRADITIONAL)
ATTN: WAYNE  GLOVER               PHONE NO : 813 920 4795
19404 PINE VALLEY DR.             SE DECISION MADE: 10-FEB-11
ODESSA FL 33556                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
BIONOSTICS, INC.                  510(k) NO: K103553(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 772 7070
7 JACKSON RD.                     SE DECISION MADE: 10-FEB-11
DEVENS MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX FUSION SYSTEM
LANX, LLC                         510(k) NO: K102738(TRADITIONAL)
ATTN: ALAN  BURKHOLDER            PHONE NO : 303 443 7500
390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 10-FEB-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASTERSCREEN IOS
CAREFUSION GERMANY 234 GMBH       510(k) NO: K101873(TRADITIONAL)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 10-FEB-11
HOECHBERG    GM 97204             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103101(TRADITIONAL)
ATTN: KAY  SETZER                 PHONE NO : 951 914 3242
26531 YNEZ RD.                    SE DECISION MADE: 10-FEB-11
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC.                    510(k) NO: K093745(TRADITIONAL)
ATTN: LISA  MCGRATH               PHONE NO : 408 956 4446
1000 GIBRALTAR DR., MS 2C         SE DECISION MADE: 11-FEB-11
MILPITAS CA 95035 6312            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
MICROGENICS CORP.                 510(k) NO: K100144(TRADITIONAL)
ATTN: LISA  CHARTER               PHONE NO : 510 979 5142
46360 FREMONT BLVD                SE DECISION MADE: 11-FEB-11
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE ORAL FLUID COCAINE
ROCHE DIAGNOSTICS                 510(k) NO: K101160(TRADITIONAL)
ATTN: MICHELLE LEE  NEFF          PHONE NO : 317 521 2000
9115 HAGUE ROAD                   SE DECISION MADE: 11-FEB-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSLOC MINI V3
JMS NORTH AMERICA CORPORATION     510(k) NO: K110157(SPECIAL)
ATTN: E. J SMITH                  PHONE NO : 410 451 0639
1468 HARWELL AVE.                 SE DECISION MADE: 11-FEB-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
BOSTON SCIENTIFIC CORP.           510(k) NO: K102714(TRADITIONAL)
ATTN: DEBBIE  MCINTIRE            PHONE NO : 408 935 4679
ONE SCIMED PLACE                  SE DECISION MADE: 11-FEB-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
MEDTRONIC INC.                    510(k) NO: K103386(SPECIAL)
ATTN: ANU  GAUR                   PHONE NO : 978 739 3080
35-37A CHERRY HILL DRIVE          SE DECISION MADE: 11-FEB-11
DANVERS MA 01923 5186             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
ROCHE DIAGNOSTICS                 510(k) NO: K093867(TRADITIONAL)
ATTN: MICHELLE  LEE NEFF          PHONE NO : 317 521 2000
9115 HAGUE ROAD                   SE DECISION MADE: 11-FEB-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISUALIZE: VASCULAR
THE MEDIPATTERN CORPORATION       510(k) NO: K103761(TRADITIONAL)
ATTN: ERIN  WALSH                 PHONE NO : 416 744 0009#250
3080 YOUNGE STREET SUITE 4070     SE DECISION MADE: 11-FEB-11
TORONTO, ON    CA M4N 3N1         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS ANTI-TPO CALSET
ROCHE DIAGNOSTICS                 510(k) NO: K103171(TRADITIONAL)
ATTN: SARAH  BAUMANN              PHONE NO : 317 521 3952
9115 HAGUE ROAD P.O. BOX 50416    SE DECISION MADE: 11-FEB-11
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
EDWARDS LIFESCIENCES LLC          510(k) NO: K110103(SPECIAL)
ATTN: SPENCER  WALKER             PHONE NO : 801 565 6103
12050 LONE PEAK PARKWAY           SE DECISION MADE: 11-FEB-11
DRAPER UT 84020 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSAFITCUP CC TRIO
MEDACTA INTERNATIONAL             510(k) NO: K103352(TRADITIONAL)
ATTN: NATALIE J KENNEL            PHONE NO : 858 705 0350
13721 VIA TRES VISTA              SE DECISION MADE: 11-FEB-11
SAN DIEGO CA 92129                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
BREATHE TECHNOLOGIES, INC.        510(k) NO: K103345(TRADITIONAL)
ATTN: JOSEPH  CIPILLONE           PHONE NO : 925 359 1508
4000 EXECUTIVE PARKWAY, SUITE 190 SE DECISION MADE: 11-FEB-11
SAN RAMON CA 94583                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
SHERPA KOREA                      510(k) NO: K103346(TRADITIONAL)
ATTN: RAYMOND  KELLY              PHONE NO : 603 595 0095
56B SHADOWBROOK DR                SE DECISION MADE: 11-FEB-11
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: SUPERDIMENSION MARKER DELIVERY KIT
SUPERDIMENSION INC.               510(k) NO: K110093(SPECIAL)
ATTN: JONATHAN  KOVACH            PHONE NO : 763 210 4015
161 CHESHIRE LANE NORTH SUITE 100 SE DECISION MADE: 11-FEB-11
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4CIS VANE SPINE SYSTEM
SOLCO BIOMEDICAL CO., LTD.        510(k) NO: K101818(TRADITIONAL)
ATTN: SAEYOUNG  AHN               PHONE NO : 301 602 4014
9700 GREAT SENECA HWY SUITE 302   SE DECISION MADE: 11-FEB-11
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NC TREK RX CORONARY DILATATION CATHETER
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K110134(SPECIAL)
ATTN: SUZANNE  REDMAN             PHONE NO : 951 914 3243
26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 11-FEB-11
TEMECULA CA 92589 9018            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIVO MR355, OPTIMA MR360
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K103330(TRADITIONAL)
ATTN: RUOQIAN  LIU                PHONE NO : 861 058 068943
NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 11-FEB-11
BEIJING    CH 100176              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
BRIGHT SPINE, INC                 510(k) NO: K102449(TRADITIONAL)
ATTN: ROBERT  SIMONSON            PHONE NO : 561 289 9378
799 N.E. 71ST STREET              SE DECISION MADE: 11-FEB-11
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
SAMSUNG MOBILE DISPLAY CO., LTD   510(k) NO: K102321(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 832 623 2099
333 MEADOWLANDS PKWY #303         SE DECISION MADE: 11-FEB-11
SECAUCUS NJ 07094                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T OPTIMA MR430S
GE MEDICAL SYSTEMS, LLC           510(k) NO: K103238(TRADITIONAL)
ATTN: NORMA  LEMAY                PHONE NO : 781 262 5581
301 BALLARDVALE STREET SUITE 4    SE DECISION MADE: 11-FEB-11
WILMINGTON MA 01887               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: O2-IN-A-BOX, O2-IN-A-BOX
GETO2, INC.                       510(k) NO: K102750(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE              SE DECISION MADE: 11-FEB-11
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AS3700 ANESTHSIA DELIVERY SYSTEM
MINDRAY DS USA, INC.              510(k) NO: K102471(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391
800 MACARTHUR BLVD                SE DECISION MADE: 11-FEB-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART READ BIOLOGICAL TEST PACK
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K103000(SPECIAL)
ATTN: SUZANNE  DENNIS             PHONE NO : 303 660 4201
74 INVERNESS DRIVE EAST           SE DECISION MADE: 11-FEB-11
ENGLEWOOD CO 80112                510(k) STATEMENT

DEVICE: FUSTAR STEERABLE INTRODUCERS
LIFETECH SCIENTIFIC (SHENZHEN) CO.510(k) NO: K100184(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 216 4684973
# 19, LN 999, ZHONGSHAN RD S2 SUITSE DECISION MADE: 14-FEB-11
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELIO CS INLAY & TELIO CS ONLAY
IVOCLAR VIVADENT, INC.            510(k) NO: K103379(TRADITIONAL)
ATTN: DONNA M HARTNETT            PHONE NO : 716 691 0010
175 PINEVIEW DR.                  SE DECISION MADE: 14-FEB-11
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
DENTSPLY INTL., INC.              510(k) NO: K103244(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 845 7511
SUSQUEHANNA COMMERCE CENTER 221 W SE DECISION MADE: 14-FEB-11
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
A JOHNSON & JOHNSON COMPANY       510(k) NO: K103491(SPECIAL)
ATTN: FRANK S JURCZAK             PHONE NO : 508 828 3288
325 PARAMOUNT DRIVE               SE DECISION MADE: 14-FEB-11
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISA HBA1C, MODEL K3105A
SIEMENS HEATLHCARE DIAGNOSTICS INC510(k) NO: K102045(TRADITIONAL)
ATTN: ANNA-MARIE K ENNIS          PHONE NO : 302 631 9352
500 GBC DRIVE P.O. BOX 6101       SE DECISION MADE: 14-FEB-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT GRAFT SCREW
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K103084(TRADITIONAL)
ATTN: DAVID J COLLETTE            PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 14-FEB-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
SURGICRAFT LTD.                   510(k) NO: K091207(TRADITIONAL)
ATTN: DONALD W GUTHNER            PHONE NO : 646 460 2984
111 HILL ROAD                     SE DECISION MADE: 15-FEB-11
DOUGLASSVILLE PA 19518            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFINION ANALYZER
AXIS-SHIELD POC AS                510(k) NO: K110056(TRADITIONAL)
ATTN: KARI  SKINNEMOEN            PHONE NO : 472 405 6000
P.O. BOX 6863 RODELOKKA           SE DECISION MADE: 15-FEB-11
OSLO    NO N-0504                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRIUM CENTRILFX MESH
ATRIUM MEDICAL CORPORATION        510(k) NO: K110110(SPECIAL)
ATTN: RAYMOND J KELLY             PHONE NO : 603 880 1433
5 WENTWORTH DR                    SE DECISION MADE: 15-FEB-11
HUDSON NH 03051                   510(k) STATEMENT

DEVICE: ADVANCED MEMBRANE GAS EXCHANGE ("AMG"), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
EUROSETS S.R.L.                   510(k) NO: K102109(TRADITIONAL)
ATTN: MARIO  GENMARI              PHONE NO : 003 905 3552161
VIA G. PUCCINI, 1                 SE DECISION MADE: 15-FEB-11
MEDOLLA, MODENA    IT I-43036     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K103753(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251 163294
FABRIKSTRASSE 31                  SE DECISION MADE: 15-FEB-11
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K110176(SPECIAL)
ATTN: ANTHONY  DENNIS             PHONE NO : 201 831 5804
325 CORPORATE DRIVE               SE DECISION MADE: 15-FEB-11
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSL ANTERIOR CERVICAL PLATE SYSTEM
PRECISION SURGERY LTD.            510(k) NO: K103819(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457
8202 SHERMAN ROAD                 SE DECISION MADE: 15-FEB-11
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
PRECISION SURGERY LTD.            510(k) NO: K103838(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD.        PHONE NO : 440 729 8457
8202 SHERMAN ROAD                 SE DECISION MADE: 15-FEB-11
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESS ENDOSCOPE
ENTELLUS MEDICAL, INC.            510(k) NO: K102366(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7056
6705 WEDGWOOD COURT NORTH         SE DECISION MADE: 15-FEB-11
MAPLE GROVE MN 55311              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE ABI
SUMMIT DOPPLER SYSTEMS, INC.      510(k) NO: K103693(TRADITIONAL)
ATTN: KEN  JARRELL                PHONE NO : 303 423 7572
4680 TABLE MOUNTAIN DR #150       SE DECISION MADE: 15-FEB-11
GOLDEN CO 80403                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ARM AUTOMATIC BLOOD PRESSURE METER, MODELS FT-C21Y, FT-C22Y, FT-C23Y, FT-C24Y, FT-C11B, FT-C12B, FT-C21Y-V, FT-C22Y-V
FUDAKANG INDUSTRIAL CO LTD        510(k) NO: K110281(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 86 755 83089699
ZHONGFANG JIN YUAN BLDG XINWEN ROASE DECISION MADE: 15-FEB-11
SHENZHEN, GUANGDONG    CH 518034  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PHILIPS ECG LEADWIRE SET
PHILIPS MEDICAL SYSTEMS           510(k) NO: K110287(ABBREVIATED)
ATTN: PETER  SCHIPELLITI          PHONE NO : 978 659 4744
3000 MINUTEMAN RD.                SE DECISION MADE: 15-FEB-11
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRABECULAR METAL FEMORAL CONE AUGMENTS
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K103517(TRADITIONAL)
ATTN: JUDITH  ROSEN               PHONE NO : 973 576 0032
10 POMEROY RD.                    SE DECISION MADE: 15-FEB-11
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR
ORTHOCON, INC.                    510(k) NO: K102762(TRADITIONAL)
ATTN: BRIAN  KUNST                PHONE NO : 914 357 2600
1 BRIDGE STREET, SUITE 121        SE DECISION MADE: 15-FEB-11
IRVINGTON NY 10533                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSTEMS INTEGRATION
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K102763(SPECIAL)
ATTN: STACY  ABBATIELLO           PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY            SE DECISION MADE: 15-FEB-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENZYME II CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103836(TRADITIONAL)
ATTN: ANNA MARIE KATH  ENNIS      PHONE NO : 302 631 9352
500 GBC DRIVE P.O. BOX 6101       SE DECISION MADE: 16-FEB-11
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZENOSTAR MAGIC GLAZE
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K103494(TRADITIONAL)
ATTN: GERHARD  POLZER             PHONE NO : 490 723 13705219
SCHWENNINGER STRABE 13            SE DECISION MADE: 16-FEB-11
PFORZHEIM    GM D-75179           510(k) STATEMENT

DEVICE: GDC 360 DETEACHABLE COIL
BOSTON SCIENTIFIC CORP.           510(k) NO: K103355(TRADITIONAL)
ATTN: RHODA M SANTOS              PHONE NO : 510 624 1262
47900 BAYSIDE PARKWAY             SE DECISION MADE: 16-FEB-11
FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O
CONMED CORPORATION                510(k) NO: K103665(TRADITIONAL)
ATTN: SHAWN  RIEDEL               PHONE NO : 303 269 8224
14603 E. FREMONT AVE.             SE DECISION MADE: 16-FEB-11
CENTENNIAL CO 80112               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
ARTHROCARE CORP.                  510(k) NO: K110183(SPECIAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224
680 VAQUEROS AVE.                 SE DECISION MADE: 16-FEB-11
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
DANA PRODUCTS, INC.               510(k) NO: K103321(TRADITIONAL)
ATTN: HARRY  BALA                 PHONE NO : 847 455 2881
7 COREY DR.                       SE DECISION MADE: 16-FEB-11
SOUTH BARRINGTON IL 60010         510(k) STATEMENT

DEVICE: CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103678(TRADITIONAL)
ATTN: ALBRECHT  MALKMUS           PHONE NO : 497 614 543481
MUNZINGER STRASSE 5               SE DECISION MADE: 16-FEB-11
FREIBURG,BADEN WURTTEMBERG    GM 7510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAREX ULTRASOUND GEL
DYNAREX CORPORATION               510(k) NO: K102637(TRADITIONAL)
ATTN: DANIEL  CONSAGA             PHONE NO : 845 365 8200
10 GLENSHAW ST.                   SE DECISION MADE: 16-FEB-11
ORANGEBURG NY 10962               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TECO DIAGNOSTICS UTI DETECTION STRIPS
TECO DIAGNOSTICS                  510(k) NO: K100024(TRADITIONAL)
ATTN: KC  CHEN                    PHONE NO : 714 225 9979
1268 NORTH LAKEVIEW AVE.          SE DECISION MADE: 17-FEB-11
ANAHEIM CA 92807                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD.                   510(k) NO: K110207(TRADITIONAL)
ATTN: RICHARD  CEHOVSKY           PHONE NO : 800 872 5652
10 FAIRFIELD BLVD.                SE DECISION MADE: 17-FEB-11
WALLINGFORD CT 06492 7502         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K110168(SPECIAL)
ATTN: EILEEN M BOYLE              PHONE NO : 978 421 9171
269 MILL ROAD                     SE DECISION MADE: 17-FEB-11
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEL-CYPHER N
TAKARA BELMONT CORPORATION        510(k) NO: K110160(SPECIAL)
ATTN: KUNIHIKO  SOBUE             PHONE NO : 732 469 5000
101 BELMONT DR                    SE DECISION MADE: 17-FEB-11
SOMERSET NJ 08873                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GOLIFE NASAL MASK
RESPIRONICS, INC.                 510(k) NO: K110008(SPECIAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146
365 PLUM INDUSTRIAL COURT         SE DECISION MADE: 17-FEB-11
PITTSBURGH PA 15239               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
SPARTEK MEDICAL, INC.             510(k) NO: K103383(SPECIAL)
ATTN: HENRY  KLYCE                PHONE NO : 510 545 4899
1100 MARINA VILLIAGE PKWY SUITE 10SE DECISION MADE: 17-FEB-11
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARITY ADVANCED CERAMIC BRACKETS
3M UNITEK CORPORATION             510(k) NO: K102803(TRADITIONAL)
ATTN: MARLYN L SCHEFF             PHONE NO : 626 574 4496
2724 SOUTH PECK RD.               SE DECISION MADE: 17-FEB-11
MONROVIA CA 91016                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
JOHNSON & JOHNSON                 510(k) NO: K103490(TRADITIONAL)
ATTN: KEVIN  STEVENS              PHONE NO : 508 977 6445
325 PARAMOUNT DR.                 SE DECISION MADE: 17-FEB-11
RAYNHAM MA 02767 0151             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-SCAN
ESAOTE S.P.A.                     510(k) NO: K110238(SPECIAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500
11460 N MERIDIAN STREET SUITE 150 SE DECISION MADE: 17-FEB-11
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
ENDYMED MEDICAL LTD               510(k) NO: K101510(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463 88837
31 HAAVODA ST.                    SE DECISION MADE: 17-FEB-11
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FILMARRAY RESPIRATORY PANEL (RP)
IDAHO TECHNOLOGY, INC.            510(k) NO: K103175(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354
390 WAKARA WAY                    SE DECISION MADE: 17-FEB-11
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K110154(SPECIAL)
ATTN: EILEEN M BOYLE              PHONE NO : 978 421 9171
269 MILL ROAD                     SE DECISION MADE: 17-FEB-11
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STIMTRODE SINGLE USE NERVE STIMULATOR
XAVANT TECHNOLOGY (PTY), LTD.     510(k) NO: K110118(SPECIAL)
ATTN: BRIAN  ROTHMAN              PHONE NO : 271 275 59491
169 GARSFONTEIN ROAD ASHLEA GARDENSE DECISION MADE: 17-FEB-11
PRETORIA, GAUTENG    SF 0081      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVOBASE HYBRID, IVOBASE HIGH IMPACT
IVOCLAR VIVADENT, INC.            510(k) NO: K103391(TRADITIONAL)
ATTN: DONNA  HARTNETT             PHONE NO : 716 691 2260
175 PINEVIEW DR.                  SE DECISION MADE: 17-FEB-11
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
CONCENTRIC MEDICAL, INC.          510(k) NO: K093610(TRADITIONAL)
ATTN: KIRSTEN  VALLEY             PHONE NO : 650 810 1707
301 E. EVELYN AVE.                SE DECISION MADE: 17-FEB-11
MOUNTAIN VIEW CA 94041            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS
USA LASER BIOTECH INC.            510(k) NO: K101893(TRADITIONAL)
ATTN: M. JOYCE  HEINRICH          PHONE NO : 713 734 4433
12101 CULLEN BOULEVARD # A        SE DECISION MADE: 17-FEB-11
HOUSTON TX 77047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCKWOOD CLAVICLE PINS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K103001(TRADITIONAL)
ATTN: SUZANNA  OTANO              PHONE NO : 305 269 6386
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 17-FEB-11
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTPACK TESTO IMMUNOASSAY
QUALIGEN, INC.                    510(k) NO: K101388(SPECIAL)
ATTN: MICHAEL S POIRIER           PHONE NO : 760 918 9165
2042 CORTE DEL NOGAL SUITE B      SE DECISION MADE: 18-FEB-11
CARLSBAD CA 92011 1438            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
REXAM PHARMA                      510(k) NO: K101233(ABBREVIATED)
ATTN: JEFFREY  BURRIS             PHONE NO : 317 346 5178
600 DEERFIELD PKWY                SE DECISION MADE: 18-FEB-11
BUFFALO GROVE IL 60089            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K110167(SPECIAL)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 756 4386
ONE EDWARDS WAY                   SE DECISION MADE: 18-FEB-11
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
VATECH CO., LTD.                  510(k) NO: K102259(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 832 623 2099
333 MEADOWLANDS PARKWAY, #303     SE DECISION MADE: 18-FEB-11
SECAUCUS NJ 07094                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUIBAND DUAL, MODEL LBD 001
MEDLOGIC GLOBAL LIMITED           510(k) NO: K102076(TRADITIONAL)
ATTN: MICHAEL  BROWNE             PHONE NO : 441 752 209955
WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 18-FEB-11
PLYMOUTH, DEVON    UK PL7 5BG     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
VAOSNOVA, INCORPORATED            510(k) NO: K103255(TRADITIONAL)
ATTN: KIM  TOMPKINS, RN, MBA      PHONE NO : 650 388 5600
155 JEFFERSON DRIVE SUITE 100     SE DECISION MADE: 18-FEB-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINITY CNAP SMARTPOD
DRAEGER MEDICAL SYSTEMS, INC.     510(k) NO: K102968(TRADITIONAL)
ATTN: JOYCE  KILROY               PHONE NO : 267 885 9989
6 TECH DRIVE                      SE DECISION MADE: 18-FEB-11
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
VAOSNOVA, INCORPORATED            510(k) NO: K103260(TRADITIONAL)
ATTN: KIM  TOMPKINS               PHONE NO : 650 388 5600
155 JEFFERSON DRIVE SUITE 100     SE DECISION MADE: 18-FEB-11
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED PULSE OXIMETER SENSORS
STERILMED, INC.                   510(k) NO: K102560(TRADITIONAL)
ATTN: GARRETT  AHLBORG            PHONE NO : 763 488 3483
11400 73RD AVE. N, STE. 100       SE DECISION MADE: 18-FEB-11
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERILIZATION MATS
STERIS CORPORATION                510(k) NO: K103226(TRADITIONAL)
ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695
5960 HEISLEY ROAD                 SE DECISION MADE: 18-FEB-11
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEMPRO MSC SFM
LIFE TECHNOLOGIES CORPORATION     510(k) NO: K103302(TRADITIONAL)
ATTN: KELLI  TANZELLA             PHONE NO : 716 774 3122
3175 STALEY ROAD                  SE DECISION MADE: 18-FEB-11
GRAND ISLAND NY 14072             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ANDON HEALTH CO.,LTD              510(k) NO: K110330(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 862 260 526161
NO 3,  JINPING STREET YA AN RD NANSE DECISION MADE: 18-FEB-11
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K103701(ABBREVIATED)
ATTN: KIRA  GORDON                PHONE NO : 914 524 2996
511 BENEDICT AVE                  SE DECISION MADE: 18-FEB-11
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT EXAMINATION GLOES
THAI HUA HOLDING CO., LTD.        510(k) NO: K102840(TRADITIONAL)
ATTN: KOK-KEE  HON                PHONE NO : 703 941 7656
6324 MEETINGHOUSE WAY             SE DECISION MADE: 18-FEB-11
ALEXANDRIA VA 22312 1718          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X2ABS DUAL CHANNEL FITNESS BELT
LETO ENTERPRISES INCORPORATION    510(k) NO: K102295(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 867 558 3089699
19/F, NAN DAO COMMERCIAL BLDG, QUESE DECISION MADE: 18-FEB-11
HONG KONG    CH 999077            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
DELTAMED GMBH                     510(k) NO: K102776(TRADITIONAL)
ATTN: EMANUEL  MESARIC            PHONE NO : 011 49 603172830
RAIFFEISENSTR. 8A                 SE DECISION MADE: 18-FEB-11
FRIEDBERG    GM D-61169           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
MORTARA INSTRUMENT, INC.          510(k) NO: K102206(ABBREVIATED)
ATTN: CHARLES  MORREALE           PHONE NO : 414 354 1600
7865 NORTH 86TH ST.               SE DECISION MADE: 18-FEB-11
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VTS1000
VUETEK SCIENTIFIC LLC             510(k) NO: K101838(TRADITIONAL)
ATTN: PAUL  SUMNER                PHONE NO : 770 448 7529
1733 CANTON LANE SUITE B          SE DECISION MADE: 18-FEB-11
MARIETTA GA 30062 2679            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SCOUT VESSEL GUARD
SYNTHES SPINE                     510(k) NO: K103558(TRADITIONAL)
ATTN: HEATHER  GUERIN             PHONE NO : 610 719 5712
1302 WRIGHTS LANE EAST            SE DECISION MADE: 18-FEB-11
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
CODMAN & SHURTLEFF, INC.          510(k) NO: K102961(SPECIAL)
ATTN: JOCELYN  RAPOSO             PHONE NO : 508 828 3421
325 PARAMOUNT DR.                 SE DECISION MADE: 18-FEB-11
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIM 5.2 (BRACHY)
MIM SOFTWARE INC.                 510(k) NO: K103576(TRADITIONAL)
ATTN: LYNN  HANIGAN               PHONE NO : 216 455 0600
25200 Chagrin Blvd. Suite 200     SE DECISION MADE: 18-FEB-11
Cleveland OH 44122                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
DERMA SCIENCES, INC.              510(k) NO: K101793(TRADITIONAL)
ATTN: RONALD S WARREN             PHONE NO : 858 753 1961
49 PLAIN STREET                   SE DECISION MADE: 22-FEB-11
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
ENVITEC-WISMAR GMBH               510(k) NO: K102270(TRADITIONAL)
ATTN: STEPHEN  GORSKI             PHONE NO : 262 594 2114
S65 W35739 PIPER ROAD             SE DECISION MADE: 22-FEB-11
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ML24000 UVA-1 PHOTOTHERAPY UNIT
THE DAAVLIN DISTRIBUTING COMPANY  510(k) NO: K103708(TRADITIONAL)
ATTN: MICHAEL  THIEL              PHONE NO : 419 636 6304
205 WEST BEMENT STREET            SE DECISION MADE: 22-FEB-11
BRYAN OH 43506                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
WAKO CHEMICALS USA, INC.          510(k) NO: K100464(TRADITIONAL)
ATTN: MARTHA  MURARI              PHONE NO : 650 210 9153
1025 TERRA BELLA AVE SUITE A      SE DECISION MADE: 23-FEB-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
BIOMET, INC.                      510(k) NO: K102125(TRADITIONAL)
ATTN: GARY  BAKER, MS, RAC        PHONE NO : 574 267 6639
56 EAST BELL DR. P.O. BOX 587     SE DECISION MADE: 23-FEB-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAFLEX
DYNAFLEX                          510(k) NO: K103076(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 23-FEB-11
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K102769(TRADITIONAL)
ATTN: DAVID  COLLETTE             PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 23-FEB-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCOM CLINICALCONNEX  CARDIOMAX
ASCOM (US), INC.                  510(k) NO: K103634(TRADITIONAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232
PO BOX 3018                       SE DECISION MADE: 23-FEB-11
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103264(TRADITIONAL)
ATTN: STACY ABBATIELL  KLUESNER, MPHONE NO : 484 896 5405
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 23-FEB-11
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INDISCAL DIGITAL MANOMETER
BAYLIS MEDICAL CO., INC.          510(k) NO: K102192(TRADITIONAL)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 602 4875
2645 MATHESON BLVD. E             SE DECISION MADE: 23-FEB-11
MISSISSAUGA, ONTARIO    CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
NIDEK INCORPORATED                510(k) NO: K110228(SPECIAL)
ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 23-FEB-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBONY PTA .035 PERIPHERAL DILATATION CATHETER
NATEC MEDICAL LTD                 510(k) NO: K103354(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674
1468 HARWELL AVENUE               SE DECISION MADE: 23-FEB-11
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V-GO INSULIN DELIVERY SYSTEM
VALERITAS, INC.                   510(k) NO: K103825(TRADITIONAL)
ATTN: SCOTT  HUIE                 PHONE NO : 508 845 1177
800 BOSTON TURNPIKE               SE DECISION MADE: 23-FEB-11
SHREWSBURY MA 01545               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
ANDON HEALTH CO.,LTD              510(k) NO: K102939(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 862 260 526161
NO 3,  JINPING STREET YA AN RD NANSE DECISION MADE: 23-FEB-11
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASTRA TECH IMPLANT SYSTEM
ASTRA TECH AB                     510(k) NO: K101732(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 23-FEB-11
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
CADWELL LAB, INC.                 510(k) NO: K103128(TRADITIONAL)
ATTN: CHRIS L BOLKAN              PHONE NO : 509 735 6481
909 NORTH KELLOGG ST.             SE DECISION MADE: 23-FEB-11
KENNEWICK WA 99336                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
MICROTEK MEDICAL, INC.            510(k) NO: K102971(TRADITIONAL)
ATTN: THOMAS B BONNER, JR.        PHONE NO : 888 844 0988
602 LEHMBERG RD.                  SE DECISION MADE: 23-FEB-11
COLUMBUS MS 39702                 510(k) STATEMENT

DEVICE: SPECTRASHIELD 9500 SURGICAL MASK
NEXERA MEDICAL, INC               510(k) NO: K090414(TRADITIONAL)
ATTN: PAUL  SALLARULO             PHONE NO : 954 495 2031
1556 EAST COMMERCIAL BLVD.        SE DECISION MADE: 24-FEB-11
OAKLAND PARK FL 33334 5752        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT SAFE LUER CAP
RETRACTABLE TECHNOLOGIES, INC.    510(k) NO: K101708(TRADITIONAL)
ATTN: RHONDA  WELLS               PHONE NO : 972 294 1010
511 LOBO LN.                      SE DECISION MADE: 24-FEB-11
LITTLE ELM TX 75068 0009          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BHDENTAL IMPLANT SYSTEM
BHDENTAL LTD                      510(k) NO: K103280(TRADITIONAL)
ATTN: EILAT  EZRA                 PHONE NO : 972 542 422555
21 HANAFA STREET                  SE DECISION MADE: 24-FEB-11
ZUR-MOSHE    IS 42810             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILS PORT
COVIDEN (FORMERLY REGISTERED AS US510(k) NO: K103253(TRADITIONAL)
ATTN: TIM M LOHNES                PHONE NO : 203 492 5462
60 MIDDLETOWN AVE.                SE DECISION MADE: 24-FEB-11
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
BIOLITEC, INC.                    510(k) NO: K110080(TRADITIONAL)
ATTN: NANCY  FOLEY                PHONE NO : 413 525 0600
515 SHAKER RD.                    SE DECISION MADE: 24-FEB-11
EAST LONGMEADOW MA 01028          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
ST. JUDE MEDICAL SYSTEMS AB       510(k) NO: K110193(SPECIAL)
ATTN: KATRIN  SVENSSON            PHONE NO : 46 18 161000
PALMBLADSGATAN 10                 SE DECISION MADE: 24-FEB-11
UPPSALA    SW SE-751 35           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE PLATE SYSTEM
N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K102597(TRADITIONAL)
ATTN: HILA  WACHSLER-AVRAHAMI     PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET              SE DECISION MADE: 24-FEB-11
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K110012(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700
3471 RIVER HILLS DR.              SE DECISION MADE: 24-FEB-11
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROPHON
NANOSONICS LIMITED                510(k) NO: K103059(TRADITIONAL)
ATTN: RON  WEINBERGER             PHONE NO : 612 806 31600
24/566 GARDENERS ROAD             SE DECISION MADE: 24-FEB-11
ALEXANDRIA, NSW    AS 2015        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
SHOULDER OPTIONS, INC.            510(k) NO: K102539(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 843 7852
100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 24-FEB-11
WAXHAW NC 28173                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VACPLUS SUCTION UNIT
APEX MEDICAL CORP.                510(k) NO: K103535(TRADITIONAL)
ATTN:                             PHONE NO :
NO.8, LANE 29, WENMING RD.        SE DECISION MADE: 24-FEB-11
GUISAN, TAOYUAN    TW 33383       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BILLY BOY MALE LATEX CONDOM
SHEILA PICKERING PH.D.            510(k) NO: K103119(TRADITIONAL)
ATTN: SHEILA W PICKERING          PHONE NO : 650 279 0668
2061 LONGDEN CIRCLE               SE DECISION MADE: 24-FEB-11
LOS ALTOS CA 94024                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K101797(TRADITIONAL)
ATTN: DAVID M HORTON              PHONE NO : 303 530 6391
5920 LONGBOW DRIVE                SE DECISION MADE: 24-FEB-11
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE BILIARY DRAINAGE STENT V
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103478(TRADITIONAL)
ATTN: STACY  ABBATIELLO KLUESNER  PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 24-FEB-11
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE FLUDI METHAMPHETAMINE
ROCHE DIAGNOSTICS                 510(k) NO: K093884(TRADITIONAL)
ATTN: MICHELLE LEE  NEFF          PHONE NO : 317 521 2000
9115 HAGUE ROAD                   SE DECISION MADE: 25-FEB-11
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
CONTRACT MEDICAL INTL. GMBH       510(k) NO: K100799(TRADITIONAL)
ATTN: JAN  KLOBOUCNIK             PHONE NO : 420 494 949564
ZUR WETTERWARTE 50                SE DECISION MADE: 25-FEB-11
DRESDEN, SACHSEN    GM 01109      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADAPT, MODEL AX-03SN
APELIOTUS VISION SCIENCE, INC     510(k) NO: K100954(TRADITIONAL)
ATTN: JOHN G EDWARDS              PHONE NO : 404 875 9561
1456 N. MORNINGSIDE DRIVE, NE     SE DECISION MADE: 25-FEB-11
ATLANTA GA 30306                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNORE GUARD
RANIR LLC                         510(k) NO: K103004(SPECIAL)
ATTN: GERARD J PRUD'HOMME         PHONE NO : 202 637 5735
555 THIRTEENTH STREET, NW         SE DECISION MADE: 25-FEB-11
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APPROACH PRO ST WIRE GUIDE
COOK INCORPORATED                 510(k) NO: K110163(SPECIAL)
ATTN: AARON  SANTNER              PHONE NO : 812 339 2235
750 DANIELS WAY                   SE DECISION MADE: 25-FEB-11
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHELON RAPID CARDIAC COIL
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K110120(ABBREVIATED)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 25-FEB-11
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHALLENGE-EVER
HALLIM DENTECH CO., LTD.          510(k) NO: K102223(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 844 2612
2341 W. CRESCENT AVE. SUITE 3     SE DECISION MADE: 25-FEB-11
ANAHEIM CA 92801                  510(k) STATEMENT

DEVICE: FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
OSTIAL CORPORATION                510(k) NO: K102482(TRADITIONAL)
ATTN: ERIC  ANKERUD, JD           PHONE NO : 650 903 9100
510 CLYDE AVENUE                  SE DECISION MADE: 25-FEB-11
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIPLE NAME
IDEAL QUALITY SDN., BHD.          510(k) NO: K103337(TRADITIONAL)
ATTN: SH  TAN                     PHONE NO : 603 329 10516
LOT 2796, 17 1/2 MILES JALAN KAPARSE DECISION MADE: 25-FEB-11
KLANG    MY 42200                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOSHIBA 1.5T EXTRA LARGE KNEE COIL
QUALITY ELECTRODYNAMICS           510(k) NO: K103185(TRADITIONAL)
ATTN: CHRISTIE  ZYDYK             PHONE NO : 440 484 2228
700 BETA DR. SUITE 100            SE DECISION MADE: 25-FEB-11
MAYFIELD VILLAGE OH 44143         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ENDOLOGIX GUIDEWIRE
TECHDEVICE CORPORATION            510(k) NO: K110241(SPECIAL)
ATTN: GARY  BUNNEWITH             PHONE NO : 617 972 5810
650 PLEASANT ST.                  SE DECISION MADE: 25-FEB-11
WATERTOWN MA 02472                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAAD 100NX EXPRESS CYCLE TEST PACK
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K092755(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 9435
33 TECHNOLOGY DR.                 SE DECISION MADE: 25-FEB-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD CYCLESURE BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K103222(TRADITIONAL)
ATTN: YOGI  SHAH                  PHONE NO : 949 789 8548
33 TECHNOLOGY DR.                 SE DECISION MADE: 25-FEB-11
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
MAQUET CARDIOPULMONARY AG         510(k) NO: K102532(TRADITIONAL)
ATTN: INGRID  RICHTER             PHONE NO : 011 497 478921337
HECHINGER STRASSE 38              SE DECISION MADE: 25-FEB-11
HIRRLINGEN    GM 72145            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD.                 510(k) NO: K103397(TRADITIONAL)
ATTN: KYEONG-MI  PARK             PHONE NO : 822 219 41373
1003  DAECHI-DONG GANGNAM-GU      SE DECISION MADE: 25-FEB-11
SEOUL    KS 135-280               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
RIVERPOINT MEDICAL                510(k) NO: K103449(ABBREVIATED)
ATTN: DOUG  ROWLEY                PHONE NO : 503 517 8001
825 NE 25TH AVE.                  SE DECISION MADE: 25-FEB-11
PORTLAND OR 97232                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-CONTACT INFRARED THERMOMETER
K-JUMP HEALTH CO., LTD.           510(k) NO: K102947(TRADITIONAL)
ATTN: JASON  CHENG                PHONE NO : 886 222 991378
NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 25-FEB-11
TAIPEI HSIEN    TW 248            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPS EMPRESS DIRECT FLOW
IVOCLAR VIVADENT, INC.            510(k) NO: K103528(TRADITIONAL)
ATTN: DONNA  HARTNETT             PHONE NO : 716 691 0010
175 PINEVIEW DR.                  SE DECISION MADE: 25-FEB-11
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
ADVANCED MEDICAL DEVICES FACTORY  510(k) NO: K103772(TRADITIONAL)
ATTN: XINGYUAN  WANG              PHONE NO : 865 362 197038
NO. 8-1 XING'AN ROAD EAST LINQU   SE DECISION MADE: 25-FEB-11
WEIFANG, SHANDONG    CH 262600    510(k) STATEMENT

DEVICE: ESCOM 100
SPIDENT CO., LTD.                 510(k) NO: K110428(TRADITIONAL)
ATTN: JE MO  AHN                  PHONE NO : 823 281 94570
KOREA INDUSTRIAL COMPLEX 722 KOJANSE DECISION MADE: 25-FEB-11
INCHEON    KS 405-821             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LUCIA
MERIDIAN CO., LTD.                510(k) NO: K102375(TRADITIONAL)
ATTN: VINOD  PODICHETTY           PHONE NO : 954 559 4213
3550 SW 148 AVENUE SUITE 110      SE DECISION MADE: 25-FEB-11
MIRAMAR FL 33027                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENERAL DENISTRY MOTOR
ASEPTICO, INC.                    510(k) NO: K103399(TRADITIONAL)
ATTN: CHERIE  TREGONING           PHONE NO : 425 487 3157
8333 216TH ST., S.E.              SE DECISION MADE: 28-FEB-11
WOODINVILLE WA 98072              510(k) STATEMENT

DEVICE: VANGUARD ASYMMETRICAL PATELLAR COMPONENT
BIOMET MANUFACTURING CORP.        510(k) NO: K110362(TRADITIONAL)
ATTN: TAMARA  WEST                PHONE NO : 574 267 6639
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 28-FEB-11
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KYPHON XPEDE BONE CEMENT
MEDTRONIC                         510(k) NO: K102397(TRADITIONAL)
ATTN: MARY  ROSE                  PHONE NO : 408 548 5203
1221 CROSSMAN AVE.                SE DECISION MADE: 28-FEB-11
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORIN BIOLOX DELTA FEMORAL HEADS
CORIN USA                         510(k) NO: K103120(TRADITIONAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 28-FEB-11
TAMPA FL 33612                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
FLEXBAR MACHINE CORP.             510(k) NO: K103840(TRADITIONAL)
ATTN: STEPHEN T MLCOCH            PHONE NO : 631 744 0059
30 NORTHPORT ROAD                 SE DECISION MADE: 28-FEB-11
SOUND BEACH NY 11764              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
LANX, INC.                        510(k) NO: K103660(SPECIAL)
ATTN: WILLIAM  SANDUL             PHONE NO : 303 501 8507
390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 28-FEB-11
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTICOR K-WIRE SYSTEM
VERTICOR, LTD                     510(k) NO: K110047(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199
1001 OAKWOOD BLVD.                SE DECISION MADE: 28-FEB-11
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   255
                                                 TOTAL WITH SUMMARIES        237
                                                 TOTAL WITH STATEMENTS        18