January 2010 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
	DECISIONS RENDERED DURING THE PERIOD January 2010


DEVICE: LIGHTWAVE PROFESSIONAL DELUXE
LIGHTWAVE TECHNOLOGIES LLC        510(k) NO: K082586(TRADITIONAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 516 8197   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 04-JAN-10
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUNG FLUTE THERAPEUTIC
MEDICAL ACOUSTICS                 510(k) NO: K091557(TRADITIONAL)
ATTN: NICOLAAS J SMIT             PHONE NO : 905 346 1876   
255 GREAT ARROW AVE. STE 23       SE DECISION MADE: 04-JAN-10
BUFFALO NY 14207                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXEL I.V. EXTENSION SET
EXELINT INTL. CO.                 510(k) NO: K092172(TRADITIONAL)
ATTN: ARMAND  HAMID               PHONE NO : 310 649 0707   
5840 WEST CENTINELA AVE.          SE DECISION MADE: 04-JAN-10
LOS ANGELES CA 90045              510(k) STATEMENT

DEVICE: TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
TRIA BEAUTY, INC.                 510(k) NO: K090312(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 05-JAN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMODILUTION CATHETER
BIOSENSORS INTL. PTE. LTD.        510(k) NO: K083384(SPECIAL)
ATTN: MOSES  THAM                 PHONE NO : 65 629 38066
21 KALLANG AVENUE #07-167         SE DECISION MADE: 05-JAN-10
SINGAPORE    SN 339412            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNO NARROW IMPLANT
M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K092555(TRADITIONAL)
ATTN: IMAN  KHORSHID              PHONE NO : 972 498 09966
P.O.B. 110 SHLOMI INDUSTRIAL ZONE SE DECISION MADE: 05-JAN-10
SHLOMI    IS 22832                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
COOPERVISION, INC.                510(k) NO: K091339(TRADITIONAL)
ATTN: LISA  HAHN                  PHONE NO : 757 664 2421   
1215 BOISSEVAIN AVE.              SE DECISION MADE: 05-JAN-10
NORFOLK VA 23507                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIKRO-CATH, MODEL 825-0101
MILLAR INSTRUMENTS, INC.          510(k) NO: K093111(ABBREVIATED)
ATTN: FATMA  ALI                  PHONE NO : 832 667 7131   
6001-A GULF FREEWAY               SE DECISION MADE: 05-JAN-10
HOUSTON TX 77023 5417             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVOSIGHT TOPICAL OCT SYSTEM
MICHELSON DIAGNOSTICS LTD.        510(k) NO: K093520(TRADITIONAL)
ATTN: MARTIN  JOHNS               PHONE NO : 44 208 3081695
11A GRAYS FARM PRODUCTION VILL GRASE DECISION MADE: 05-JAN-10
ORPINGTON, KENT    UK BR5 3BD     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION SYSTEM
ECLIPSEMED GLOBAL, INC            510(k) NO: K093465(TRADITIONAL)
ATTN: IGOR  GRADOV                PHONE NO : 972 380 2911   
16850 DALLAS PARKWAY              SE DECISION MADE: 05-JAN-10
DALLAS TX 75248                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICHIGAN CRANIAL RESHAPING ORTHOSIS
DANMAR PRODUCTS, INC.             510(k) NO: K090341(TRADITIONAL)
ATTN: KAY  FULLER, RAC            PHONE NO : 734 274 4680   
537 FORT DEARBORN STREET          SE DECISION MADE: 06-JAN-10
DEARBORN MI 48124                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
HANJIN DIGI-X CO., LTD.           510(k) NO: K092772(TRADITIONAL)
ATTN: SHIN  KUK YOO               PHONE NO : 801 303 7440   
215 S. STATE STREET SUITE 100B    SE DECISION MADE: 06-JAN-10
SALT LAKE CITY UT 84111           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
SOLCO BIOMEDICAL CO., LTD.        510(k) NO: K092162(TRADITIONAL)
ATTN: SAEYOUNG  AHN               PHONE NO : 301 279 5453   
155 GIBBS ST., SUITE 510          SE DECISION MADE: 06-JAN-10
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYTORI PUREGRAFT 250/PURE SYSTEM
CYTORI THERAPEUTICS, INC.         510(k) NO: K092923(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ         PHONE NO : 858 458 0900   
3020 CALLAN ROAD                  SE DECISION MADE: 06-JAN-10
SAN DIEGO CA 92121 1109           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAX FILM PROCESSOR
VELOPEX INTERNATIONAL, INC.       510(k) NO: K093503(TRADITIONAL)
ATTN: ANTHONY  URELLA             PHONE NO : 407 957 3900   
105 EAST 17TH ST.                 SE DECISION MADE: 06-JAN-10
ST. CLOUD FL 34769                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3D ASL
GE MEDICAL SYSTEMS, LLC           510(k) NO: K092925(TRADITIONAL)
ATTN: YUAN  MA                    PHONE NO : 262 521 6223   
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 06-JAN-10
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
CONSEAL INTERNATIONAL, INC.       510(k) NO: K090345(TRADITIONAL)
ATTN: STEPHEN C PERRY             PHONE NO : 781 278 0010   
90 KERRY PL, SUITE 2              SE DECISION MADE: 07-JAN-10
NORWOOD MA 02062                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIO-WRAP
MAST BIOSURGERY USA INC.          510(k) NO: K090637(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ         PHONE NO : 858 550 8050   
6749 TOP GUN ST., SUITE C         SE DECISION MADE: 07-JAN-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
CHAMPIONS IMPLANTS GMBH           510(k) NO: K091182(TRADITIONAL)
ATTN: MARCUS  WEINACKER           PHONE NO : 497 464 9809452
JAHNSTRASSE 14                    SE DECISION MADE: 07-JAN-10
TUNINGEN, BADEN-WUERTTEMBERG    GM510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
SERIM RESEARCH CORP.              510(k) NO: K092346(TRADITIONAL)
ATTN: PATRICIA  RUPCHOCK          PHONE NO : 574 264 3440   
3506 REEDY DR.                    SE DECISION MADE: 07-JAN-10
ELKHART IN 46561                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POGS, MODEL 65/130
ON SITE GAS SYSTEMS, INC.         510(k) NO: K092636(TRADITIONAL)
ATTN: GUY  HATCH                  PHONE NO : 860 667 8888   
35 BUDNEY RD.                     SE DECISION MADE: 07-JAN-10
NEWINGTON CT 06111                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INF 4160 PLUS, MODEL D-FJ31F
FUJI DYNAMICS LIMITED             510(k) NO: K092780(TRADITIONAL)
ATTN: CHING KONG  LEE             PHONE NO : 852 278 64218
23/F., UNIT 1-3, 788 CHEUNG SHA WASE DECISION MADE: 07-JAN-10
KOWLOON, HONG KONG    CH          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
HANGZHOU HUA'AN MEDICAL & HEALTH I510(k) NO: K092447(TRADITIONAL)
ATTN: JI  BO                      PHONE NO : 86 571 88734065
BLDG 2, BAIMIAO IND. PARK ECONOMICSE DECISION MADE: 07-JAN-10
WUCHANG, HANGZHOU, ZHEJIANG    CH 510(k) STATEMENT

DEVICE: MOUNTAINEER LAMINOPLASTY SYSTEM
DEPUY SPINE, INC.                 510(k) NO: K091994(TRADITIONAL)
ATTN: DAPHNEY  GERMAIN            PHONE NO : 508 880 8395   
325 PARAMOUNT DR.                 SE DECISION MADE: 07-JAN-10
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOMAX CORDLESS ENDODONTIC HANDPIECE
DENTAMERICA                       510(k) NO: K092833(TRADITIONAL)
ATTN: ERIC  HUANG                 PHONE NO : 626 912 1388   
18688 E SAN JOSE AVE              SE DECISION MADE: 07-JAN-10
INDUSTRY CA 91748                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
EXACTECH, INC.                    510(k) NO: K092900(TRADITIONAL)
ATTN: TARA R PATTERSON            PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 07-JAN-10
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE CURAD WOUND DRESSINGS
MEDLINE INDUSTRIES, INC.          510(k) NO: K093349(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PL.                   SE DECISION MADE: 07-JAN-10
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: VIDAR DENTAL FILM DIGITIZER
VIDAR SYSTEMS CORP.               510(k) NO: K093809(TRADITIONAL)
ATTN: CARRIE L BRANCART           PHONE NO : 703 471 7070   
365 HERNDON PARKWAY               SE DECISION MADE: 07-JAN-10
HERNDON VA 20170                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VARI-LASE ENDOVENOUS LASER CONSOLE
VASCULAR SOLUTIONS, INC.          510(k) NO: K093502(SPECIAL)
ATTN: JENNIFER  RUETHER           PHONE NO : 763 656 4730   
6464 SYCAMORE COURT               SE DECISION MADE: 07-JAN-10
MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI RAIL EXTERNAL FIXATOR SYSTEM
SMALL BONE INNOVATIONS, INC.      510(k) NO: K093550(SPECIAL)
ATTN: JOHN  MINIER                PHONE NO : 215 337 6348   
1380 S. PENNSYLVANIA AVE.         SE DECISION MADE: 07-JAN-10
MORRISVILLE PA 19067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
VASCUTEK LTD.                     510(k) NO: K093817(SPECIAL)
ATTN: KAREN  KELSO                PHONE NO : 141 812 5555
NEWMAINS AVE. INCHINNAN INDUSTRIALSE DECISION MADE: 07-JAN-10
RENFREWSHIRE, GLASGOW    UK PA4 9R510(k) STATEMENT

DEVICE: MATRIX RF APPLICATOR
SYNERON MEDICAL LTD.              510(k) NO: K090025(TRADITIONAL)
ATTN: YONI  IGER                  PHONE NO : 972 543 003176
P.O. BOX 550 INDUSTRIAL ZONE      SE DECISION MADE: 08-JAN-10
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
DEMETECH CORP.                    510(k) NO: K082097(TRADITIONAL)
ATTN: ANTHONY J DIMERCURIO        PHONE NO : 305 597 5277   
8935 NW 27TH STREET               SE DECISION MADE: 08-JAN-10
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
VATECH CO., LTD.                  510(k) NO: K090467(TRADITIONAL)
ATTN: VINCENT  LEE                PHONE NO : 281 598 8110   
256 NORTH SAM HOUSTON PKWY E. SUITSE DECISION MADE: 08-JAN-10
HOUSTON TX 77060                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOSS
ED. GEISTLICH SOEHNE AG FUR CHEMIS510(k) NO: K090401(TRADITIONAL)
ATTN: PETER S REICHERTZ           PHONE NO : 202 772 5333   
1300 I STREET, N.W., 11TH FL EAST SE DECISION MADE: 08-JAN-10
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
R4 VASCULAR, INC.                 510(k) NO: K091506(TRADITIONAL)
ATTN: LAURIE  LEWANDOWSKI         PHONE NO : 763 494 8400   
7550 MERIDIAN CIR. N              SE DECISION MADE: 08-JAN-10
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K092652(SPECIAL)
ATTN: LEI  CHEN                   PHONE NO : 861 088 790480
BAILANGUYAN BLDG B 1127-1128 FUXINSE DECISION MADE: 08-JAN-10
BEIJING    CH 100039              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO-STICK SET
MEDCOMP                           510(k) NO: K091954(TRADITIONAL)
ATTN: SUSAN  PILEGGI              PHONE NO : 215 256 4201   
1499 DELP DR.                     SE DECISION MADE: 08-JAN-10
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OC-SENSOR DIANA IFOB TEST
EIKEN CHEMICAL CO., LTD.          510(k) NO: K092330(TRADITIONAL)
ATTN:                             PHONE NO : 
4-19-9, TAITO, TAITO-KU           SE DECISION MADE: 08-JAN-10
TOKYO    JA 110-8408              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
DIMEDA INSTRUMENTE GMBH           510(k) NO: K092827(TRADITIONAL)
ATTN: ANDREA  PECSI               PHONE NO : 497 462 924051
SCHWARZWALDSTRABE 5               SE DECISION MADE: 08-JAN-10
TUTTLINGEN    GM 78532            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PCR ELEVA 1.2
PHILIPS MEDICAL SYSTEMS, INC.     510(k) NO: K093355(SPECIAL)
ATTN: LYNN  HARMER                PHONE NO : 425 487 7312   
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 08-JAN-10
BOTHELL WA 98041                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
COOK, INC.                        510(k) NO: K093469(SPECIAL)
ATTN: SUSANNE  GALIN              PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 08-JAN-10
BLOOMINGTON IN 47402 0489         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALO ABLATION CATHETER, MODEL 90-9100
BARRX MEDICAL, INCORPORATED       510(k) NO: K093008(TRADITIONAL)
ATTN: VIORICA  FILIMON            PHONE NO : 408 328 7302   
540 OAKMEAD PARKWAY               SE DECISION MADE: 08-JAN-10
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD PRESSURE MONITOR, MODEL MD200A
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K093013(TRADITIONAL)
ATTN: LEE  FU                     PHONE NO : 862 164 684973
SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 08-JAN-10
SHANGHAI    CH 20030              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARDYDISK AST TELAVANCIN,30UG
HARDY DIAGNOSTICS                 510(k) NO: K093807(TRADITIONAL)
ATTN: WENDY  PHILIPS              PHONE NO : 805 346 2766   
1430 WEST MCCOY LN.               SE DECISION MADE: 08-JAN-10
SANTA MARIA CA 93455              510(k) STATEMENT

DEVICE: XELERIS 3 PROCESSING AND REVIEW WORKSTATION
GE MEDICAL SYSTEMS F.I. HAIFA     510(k) NO: K093982(TRADITIONAL)
ATTN: ELI  WERNER                 PHONE NO : 972 485 63666
4 HAYOZMA ST.                     SE DECISION MADE: 08-JAN-10
TIRAT HACARMEL    IS 30200        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
DYN'R                             510(k) NO: K092479(TRADITIONAL)
ATTN: XAVIER  ISNARD              PHONE NO : 335 622 31900
73 RUE LOUGE                      SE DECISION MADE: 11-JAN-10
MURET    FR 31600                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)SYNTHES (USA)                     510(k) NO: K092909(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610 719 6940   
1301 GOSHEN PKWY.                 SE DECISION MADE: 11-JAN-10
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
EXACTECH, INC.                    510(k) NO: K093360(SPECIAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 11-JAN-10
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPLORER 4D TREATMENT PLANNING SYSTEM
AMERICAN RADIOSURGERY, INC.       510(k) NO: K093588(TRADITIONAL)
ATTN: DAN  OLIVIER                PHONE NO : 858 675 8200   
16787 BERNARDO CENTER DR. SUITE A-SE DECISION MADE: 11-JAN-10
SAN DIEGO CA 92128                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
C-LINK MICRO IMAGING, INC         510(k) NO: K092739(TRADITIONAL)
ATTN: MARY P GALLUP               PHONE NO : 510 441 4017   
721 SANDOVAL WAY                  SE DECISION MADE: 12-JAN-10
HAYWARD CA 94544                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFENET SYSTEM
PHYSIO-CONTROL, INC.              510(k) NO: K093925(SPECIAL)
ATTN: TERESA  DAVIDSON            PHONE NO : 425 867 4333   
11811 WILLOWS ROAD NORTHEAST P.O. SE DECISION MADE: 12-JAN-10
REDMOND WA 98073 9706             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESPIRE 7900, AESPIRE VIEW
DATEX-OHMEDA INC., A DIVISION OF I510(k) NO: K092864(SPECIAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 608 221 1551   
PO BOX 7550 3030 OHMEDA DRIVE     SE DECISION MADE: 12-JAN-10
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUMOS, MODEL R 72B
LUMOS, INC                        510(k) NO: K093596(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8726 FERRARA CT                   SE DECISION MADE: 12-JAN-10
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOGRAPHIC CATHETER, MODEL ANGIOS
OSCOR INC.                        510(k) NO: K092118(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-JAN-10
PALM HARBOR FL 34683              510(k) STATEMENT

DEVICE: SOPROLIFE
SOPRO                             510(k) NO: K092583(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   
124 GAITHER DRIVE SUITE 140       SE DECISION MADE: 13-JAN-10
MT. LAUREL NJ 08054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
ANDON HEALTH CO.,LTD              510(k) NO: K092811(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 862 260 5261618060
NO 31, CHANGJIANG ROAD NANKAI DISTSE DECISION MADE: 13-JAN-10
TIANJIN    CH 300193              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SLEEP
THE SNORE RELIEVER COMPANY LLC    510(k) NO: K092942(TRADITIONAL)
ATTN: NICOLAAS  BESSELING         PHONE NO : 949 466 7472   
28711 JAEGER DRIVE                SE DECISION MADE: 13-JAN-10
LAGUNA NIGUEL CA 92677            510(k) STATEMENT

DEVICE: ASTHMA MONITOR AM3
CAREFUSION GERMANY 234 GMBH       510(k) NO: K092890(SPECIAL)
ATTN: ELMAR  NIDERMEYER           PHONE NO : 499 314 972361
LEIBNIZSTRASSE 7                  SE DECISION MADE: 13-JAN-10
HOECHBERG    GM 97204             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
LEVITRONIX LLC.                   510(k) NO: K093832(SPECIAL)
ATTN: SUSAN K HAMANN              PHONE NO : 781 466 6553   
45 FIRST AVE.                     SE DECISION MADE: 13-JAN-10
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVALVE STEERABLE GUIDE CATHETER
EVALVE INC                        510(k) NO: K093866(SPECIAL)
ATTN: SEVRINA  CIUCCI             PHONE NO : 408 316 4837   
4045 CAMPBELL AVENUE              SE DECISION MADE: 13-JAN-10
MENLO PARK CA 94025               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
AMBU A/S                          510(k) NO: K093825(SPECIAL)
ATTN: SANJAY  PARIKH              PHONE NO : 410 768 6464   
6740 BAYMEADOW DR.                SE DECISION MADE: 13-JAN-10
GLEN BURNIE MD 21060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
INFOPIA CO., LTD                  510(k) NO: K082275(TRADITIONAL)
ATTN: MARIA F GRIFFIN             PHONE NO : 704 516 8197   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 14-JAN-10
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROCOAT MESH
PROMETHEAN SURGICAL DEVICES, INC. 510(k) NO: K090271(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ         PHONE NO : 858 458 0900   
111 ROBERTS ST., SUITE G2         SE DECISION MADE: 14-JAN-10
EAST HARTFORD CT 06108            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K091867(TRADITIONAL)
ATTN: CLARE  SANTULLI             PHONE NO : 914 524 2701   
511 BENEDICT AVENUE               SE DECISION MADE: 14-JAN-10
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
STERILMED, INC.                   510(k) NO: K092158(TRADITIONAL)
ATTN: DENNIS  TOUSSAINT           PHONE NO : 763 488 3410   
11400 73RD AVE. NORTH, #100       SE DECISION MADE: 14-JAN-10
MAPLE GROVE MN 55369              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCENSION METAL GREAT TOE SYSTEM
ASCENSION ORTHOPEDICS, INC.       510(k) NO: K092047(TRADITIONAL)
ATTN: DEBBIE  STEARNS             PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 14-JAN-10
AUSTIN TX 78754 3832              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT2011 SONICSTIMU PAIN RELIEF DEVICE
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K092627(TRADITIONAL)
ATTN: ZHIGNAG  ZHAO               PHONE NO : 86 755 27652471
XILIXIAOBAIMANG                   SE DECISION MADE: 14-JAN-10
SHENZHEN, GUANGDONG    CH 518108  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE HYPODERMIC NEEDLE
FEEL TECH                         510(k) NO: K092831(TRADITIONAL)
ATTN: PETER  CHUN                 PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 14-JAN-10
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
TYTAN MEDICAL CORP.               510(k) NO: K092893(TRADITIONAL)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5208829
NO 58, FU-CHIUN ST.               SE DECISION MADE: 14-JAN-10
HSIN-CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAF (SELF ADJUSTING FILE)REDENT-NOVA LTD.                  510(k) NO: K092933(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
COLUMBIA SQUARE 555 THIRTEENTH STRSE DECISION MADE: 14-JAN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALBOGRAFT VASCULAR PROSTHESIS
LEMAITRE VASCULAR, INC.           510(k) NO: K093231(TRADITIONAL)
ATTN: ERIN  DALY                  PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 14-JAN-10
BURLINGTON MA 01803               510(k) STATEMENT

DEVICE: W&H HANDPIECE "ANESTO", MODEL: RA-5
W & H DENTALWERK BUERMOOS GMBH    510(k) NO: K083811(TRADITIONAL)
ATTN: JOHANN G SCHARL             PHONE NO : 430 627 46236297
53 IGNAZ-GLASER-STRASSE           SE DECISION MADE: 14-JAN-10
BUERMOOS    AU 5111               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
RENU MEDICAL, INC.                510(k) NO: K093658(TRADITIONAL)
ATTN: L. BRUCE  PIERSON           PHONE NO : 425 353 1110   
9800 EVERGREEN WAY                SE DECISION MADE: 14-JAN-10
EVERETT WA 98204                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
NIDEK MEDICAL PRODUCTS, INC.      510(k) NO: K093308(SPECIAL)
ATTN: JENNIFER  MCWILLIAMS        PHONE NO : 205 856 7200   
3949 VALLEY EAST INDUSTRIAL DR    SE DECISION MADE: 14-JAN-10
BIRMINGHAM AL 35217               510(k) STATEMENT

DEVICE: ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
ACE SURGICAL SUPPLY CO., INC.     510(k) NO: K093518(SPECIAL)
ATTN: J. EDWARD  CARCHIDI         PHONE NO : 508 588 3100   
1034 PEARL ST.                    SE DECISION MADE: 14-JAN-10
BROCKTON MA 02301                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
MEDTRADE PRODUCTS LTD.            510(k) NO: K093519(TRADITIONAL)
ATTN: JONATHAN D RANFIELD         PHONE NO : 44 127 0500019
ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 14-JAN-10
CREWE, CHESHIRE    UK CW1 6GL     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)EDWARDS LIFESCIENCES, LLC.        510(k) NO: K093730(SPECIAL)
ATTN: SPENCER  WALKER             PHONE NO : 801 565 6103   
6864 SOUTH 300 WEST               SE DECISION MADE: 14-JAN-10
MIDVALE UT 84047                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
C.R. BARD, INC.                   510(k) NO: K093659(SPECIAL)
ATTN: JONI  CREAL                 PHONE NO : 480 638 2906   
1625 WEST 3RD ST. P.O. BOX 1740   SE DECISION MADE: 14-JAN-10
TEMPE AZ 85280 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE COBLATOR IQ SYSTEM
ARTHROCARE CORP.                  510(k) NO: K091674(TRADITIONAL)
ATTN: VALERIE  DEFIESTA-NG        PHONE NO : 408 736 0224   
680 VAQUEROS AVE.                 SE DECISION MADE: 15-JAN-10
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K091052(TRADITIONAL)
ATTN: DENNIS M BLEILE             PHONE NO : 510 675 6515   
3240 WHIPPLE RD.                  SE DECISION MADE: 15-JAN-10
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODERN MEDICAL RESECTOSCOPE ELECTRODES
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K091511(TRADITIONAL)
ATTN: EUGENE  YEUNG               PHONE NO : 852 242 09068
35 TAI LIN PAI RD.                SE DECISION MADE: 15-JAN-10
KWAI CHUNG, HONG KONG    CH       510(k) STATEMENT

DEVICE: ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
ETHICON ENDO-SURGERY, INC.        510(k) NO: K091259(TRADITIONAL)
ATTN: RENEE  ROWE                 PHONE NO : 513 337 8243   
4545 CREEK RD.                    SE DECISION MADE: 15-JAN-10
CINCINNATI OH 45242 2839          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
NOVA BIOMEDICAL CORP.             510(k) NO: K091547(TRADITIONAL)
ATTN: PAUL  MACDONALD             PHONE NO : 781 894 0800   
200 PROSPECT ST.                  SE DECISION MADE: 15-JAN-10
WALTHAM MA 02454 9141             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
STRYKER CRANIOMAXILLOFACIAL       510(k) NO: K092743(TRADITIONAL)
ATTN: ROBERT  YAMASHITA           PHONE NO : 269 324 4258   
750 TRADE CENTRE WAY SUITE 200    SE DECISION MADE: 15-JAN-10
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART-WELL EZTEST INCUBATOR
SGM BIOTECH, INC.                 510(k) NO: K091950(TRADITIONAL)
ATTN: JOHN R GILLIS               PHONE NO : 406 585 9535   
10 EVERGREEN DR. SUITE E          SE DECISION MADE: 15-JAN-10
BOZEMAN MT 59715                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADAGIO RETRACTING ECG LEAD WIRES
ACIST MEDICAL SYSTEMS, INC.       510(k) NO: K093657(TRADITIONAL)
ATTN: AL  SAALABI                 PHONE NO : 952 941 3507   
7905 FULLER ROAD                  SE DECISION MADE: 15-JAN-10
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRUTECT TOPICAL OINTMENT, MODELS  45 GRAM TUBE, 90 GRAM TUBE
PRUGEN IP HOLDINGS, INC           510(k) NO: K092878(TRADITIONAL)
ATTN: ROBERT L KNECHTEL           PHONE NO : 480 585 0122   
8711 E PINNACLE PEAK ROAD SUITE C-SE DECISION MADE: 15-JAN-10
SCOTTSDALE AZ 85255               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALO 360 & SIZING BALLOON, MODEL 3441C
BARRX MEDICAL, INCORPORATED       510(k) NO: K093855(SPECIAL)
ATTN: VIORICA  FILIMON            PHONE NO : 408 328 7302   
540 OAKMEAD PARKWAY               SE DECISION MADE: 15-JAN-10
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORIN C5 SYSTEM MODEL 58-00-00
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K093882(SPECIAL)
ATTN: ROSINA  ROBINSON, RN, MED, RPHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 15-JAN-10
NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
COMPUMEDICS LIMITED               510(k) NO: K093223(TRADITIONAL)
ATTN: STUART  KING                PHONE NO : 613 842 07300
30-40 FLOCKHART STREET            SE DECISION MADE: 15-JAN-10
ABBOTSFORD, VICTORIA    AS 3067   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
MICROVENTION, INC.                510(k) NO: K093358(TRADITIONAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8150   
1311 VALENCIA AVE                 SE DECISION MADE: 15-JAN-10
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICA CATHETER
PENUMBRA, INC.                    510(k) NO: K093970(SPECIAL)
ATTN: SETH A SCHULMAN             PHONE NO : 510 748 3200   
1351 HARBOR BAY PKWY.             SE DECISION MADE: 15-JAN-10
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
VISGENEER, INC.                   510(k) NO: K091765(TRADITIONAL)
ATTN: EVONNE  CHEN                PHONE NO : 886 351 60111
3F-2, NO. 83, SEC. 2 GONGDAO 5TH RSE DECISION MADE: 19-JAN-10
HSINCHU CITY    TW 30070          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)KEELER LTD.                       510(k) NO: K093445(ABBREVIATED)
ATTN: EUGENE R VANARSDALE         PHONE NO : 610 353 4350   
456 PARKWAY                       SE DECISION MADE: 19-JAN-10
BROOMALL PA 19008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C. ALBICANS PNA FISH
ADVANDX, INC.                     510(k) NO: K092655(TRADITIONAL)
ATTN: PAULA E BULGER              PHONE NO : 781 376 0009   
10A ROESSLER ROAD                 SE DECISION MADE: 19-JAN-10
WOBURN MA 01801                   510(k) STATEMENT

DEVICE: BLADE ANTERIOR CERVICAL PLATE SYSTEM
NEXXT MEDICAL INC                 510(k) NO: K091936(TRADITIONAL)
ATTN: KAREN E WARDEN              PHONE NO : 440 729 8457   
8202 SHERMAN ROAD                 SE DECISION MADE: 19-JAN-10
CHESTERLAND OH 44026              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
SMALL BONE INNOVATIONS INC.       510(k) NO: K092754(TRADITIONAL)
ATTN: JOHN  MINIER                PHONE NO : 215 428 1791   
1380 SOUTH PENNSYLVANIA AVENUE    SE DECISION MADE: 19-JAN-10
MORRISVILLE PA 19067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEROX MODEL 3210
OR-NIM MEDICAL LTD.               510(k) NO: K093923(SPECIAL)
ATTN: MICHAL  BALBERG, PHD        PHONE NO : 972 892 82801
1 YODFAT ST                       SE DECISION MADE: 19-JAN-10
LOD    IS 71291                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFE SPINE LUMBAR PLATE SYSTEM
LIFE SPINE                        510(k) NO: K093200(TRADITIONAL)
ATTN: CHARLES  GILL               PHONE NO : 847 884 6117   
2401 W. HASSELL RD. SUITE 1535    SE DECISION MADE: 19-JAN-10
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
WEAR SAFE (MALAYSIA) SDN. BHD.    510(k) NO: K093500(TRADITIONAL)
ATTN: S.H.  TAN                   PHONE NO : 603 329 12657
LOT PT 13726,JALAN HAJI SALLEH OFFSE DECISION MADE: 19-JAN-10
KLANG,  SELANGOR DARUL EHSAN    MY510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3DI
SHINA SYSTEMS LTD.                510(k) NO: K093703(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 482 46632
SIRENI 6,                         SE DECISION MADE: 19-JAN-10
HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD.                 510(k) NO: K093849(TRADITIONAL)
ATTN: KYUNG-AM  SHIM              PHONE NO : 822 219 41381
1003, DAECHI-DONG GANGNANM-GU     SE DECISION MADE: 19-JAN-10
SEOUL    KS 135-280               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IMMUNOCAP RAPID READER, MODEL 12-3600-10
PHADIA US INC.                    510(k) NO: K092978(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 19-JAN-10
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
NORAS MRI PRODUCTS GMBH           510(k) NO: K093693(TRADITIONAL)
ATTN: ZAHED  SEDIGHIANI           PHONE NO : 499 312 992717
LEIBNITZSTRASSE 4                 SE DECISION MADE: 19-JAN-10
HOECHBERG    GM 97204             510(k) STATEMENT

DEVICE: ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
CIVCO MEDICAL INSTRUMENTS         510(k) NO: K093713(TRADITIONAL)
ATTN: ARTHUR  WARD                PHONE NO : 813 645 2855   
962 ALLEGRO LANE                  SE DECISION MADE: 19-JAN-10
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KERATOR
KODENT INC.                       510(k) NO: K092210(TRADITIONAL)ATTN: EUGENE  BANG                PHONE NO : 562 404 8466   
13340 E. FIRESTONE BLVD. SUITE J  SE DECISION MADE: 20-JAN-10
SANTA FE SPRINGS CA 90670         510(k) STATEMENT

DEVICE: THE PICC WAND PEELABLE SAFETY INTRODUCER
ACCESS SCIENTIFIC, INC.           510(k) NO: K093022(TRADITIONAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
12526 HIGH BLUFF DRIVE SUITE 360  SE DECISION MADE: 20-JAN-10
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
Q UROLOGICAL CORPORATION          510(k) NO: K082805(TRADITIONAL)
ATTN: SCOTT M EPSTEIN             PHONE NO : 781 245 2232   
1E MELVIN STREET P.O. BOX 793     SE DECISION MADE: 20-JAN-10
NATICK MA 01760                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)DYNACARDIA, INC.                  510(k) NO: K093172(TRADITIONAL)
ATTN:                             PHONE NO : 
1330 MOUNTAIN VIEW CIR.           SE DECISION MADE: 20-JAN-10
AZUSA CA 91702                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
MEDTRADE PRODUCTS LIMITED         510(k) NO: K093593(TRADITIONAL)
ATTN: JONATHAN  RANFIELD          PHONE NO : 441 270 500019
ELECTRA HOUSE CREW BUSINESS PARK  SE DECISION MADE: 20-JAN-10
CREWE, CHESHIRE    UK CWI 6GL     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
CALIBRA MEDICAL, INC.             510(k) NO: K093065(TRADITIONAL)
ATTN: RICHARD J MEADER            PHONE NO : 650 298 4740   
220 SAGINAW DRIVE                 SE DECISION MADE: 20-JAN-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFORM DERMAL TEMPLATE
MESYNTHES LTD                     510(k) NO: K092096(TRADITIONAL)
ATTN: MARY  MCNAMARA              PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 21-JAN-10
NORTH ATTLEBORO MA 02760 4153     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K093918(SPECIAL)
ATTN: BRIT  BAIRD                 PHONE NO : 425 636 4137   
10801 120TH AVENUE NE             SE DECISION MADE: 21-JAN-10
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
MICROVENTION, INC.                510(k) NO: K093919(SPECIAL)
ATTN: LARAINE  PANGELINA          PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 21-JAN-10
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTUM M COMPOSITE NAILING SYSTEM
N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K091425(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH ST. NW             SE DECISION MADE: 21-JAN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
AUBREY, INC.                      510(k) NO: K091863(TRADITIONAL)
ATTN: AUBREY  WOODROF             PHONE NO : 760 602 8303   
5930 SEA LION PLACE               SE DECISION MADE: 21-JAN-10
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
TRANS1 INCORPORATED               510(k) NO: K092124(TRADITIONAL)
ATTN: CHERYL  WAGONER             PHONE NO : 910 332 1700   
411 LANDMARK DR.                  SE DECISION MADE: 21-JAN-10
WILMINGTON NC 28412               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K092388(TRADITIONAL)
ATTN: PETER  ALLAN                PHONE NO : 609 936 2237   
311 ENTERPRISE DR.                SE DECISION MADE: 21-JAN-10
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDURAVENT-5 VENTILATOR
PROVIDENCE GLOBAL MEDICAL, INC.   510(k) NO: K092263(TRADITIONAL)
ATTN: HELEN  REDD                 PHONE NO : 800 292 8765   
4659 SOUTH, 2300 EAST #203        SE DECISION MADE: 21-JAN-10
SALT LAKE CITY UT 84117           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
PRAXIM MEDIVISION, SA             510(k) NO: K090953(SPECIAL)
ATTN: SEBASTIEN  BURTIN           PHONE NO : 33 476 549503
LE GRAND SABLON 4 AVENUE DE L'OBIOSE DECISION MADE: 21-JAN-10
LA TRONCHE    FR 38700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE RED RUBBER URETHRAL CATHETER
MEDLINE INDUSTRIES, INC.          510(k) NO: K092250(TRADITIONAL)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643 4785   
ONE MEDLINE PL.                   SE DECISION MADE: 21-JAN-10
MUNDELEIN IL 60060                510(k) STATEMENT

DEVICE: ODYSSEY WORKSTATION
STEREOTAXIS, INC.                 510(k) NO: K093092(SPECIAL)
ATTN: DENNIS  POZZO               PHONE NO : 314 678 6136   
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 21-JAN-10
ST. LOUIS MO 63108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
COOK IRELAND LTD                  510(k) NO: K093195(TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 353 613 34440
O'HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 21-JAN-10
LIMERICK    EI                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
FU HONG INDUSTRIES LTD.           510(k) NO: K093370(TRADITIONAL)
ATTN: KEVIN  WALLS, RAC           PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT             SE DECISION MADE: 21-JAN-10
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: DENTAL MERCURY
DMG USA, INC.                     510(k) NO: K093587(TRADITIONAL)
ATTN: PAMELA  PAPINEAU            PHONE NO : 978 772 3552   
23 FRANK MOSSBERG DRIVE           SE DECISION MADE: 21-JAN-10
ATTLEBORO MA 02703                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
MEDACTA INTERNATIONAL, SA         510(k) NO: K093944(SPECIAL)
ATTN: HEATHER  NEELY              PHONE NO : 805 886 1069   
4725 CALLE QUETZAL SUITE B        SE DECISION MADE: 21-JAN-10
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
BECTON DICKINSON & CO.            510(k) NO: K093972(SPECIAL)
ATTN: JULIE T WING                PHONE NO : 201 847 4260   
1 BECTON DRIVE, MC 300            SE DECISION MADE: 21-JAN-10
FRANKLIN LAKES NJ 07417 1880      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)INTUITIVE SURGICAL, INC.          510(k) NO: K093217(TRADITIONAL)
ATTN: KAREN  UYESUGI              PHONE NO : 408 523 2100   
950 KIFER RD.                     SE DECISION MADE: 21-JAN-10
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K093427(ABBREVIATED)
ATTN: DEBBIE  PEACOCK             PHONE NO : 203 602 3774   
419 WEST AVE.                     SE DECISION MADE: 21-JAN-10
STAMFORD CT 06902 6300            510(k) STATEMENT

DEVICE: ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K093947(TRADITIONAL)
ATTN: CAROL  HOLLOWAY, RAC        PHONE NO : 801 208 4272   
1600 WEST MERIT PKWY.             SE DECISION MADE: 21-JAN-10
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOGARTY OCCLUSION CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K093911(SPECIAL)
ATTN: PATRICIA A MILBANK          PHONE NO : 949 250 2603   
ONE EDWARDS WAY                   SE DECISION MADE: 21-JAN-10
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
ARAGON SURGICAL INC.              510(k) NO: K093075(TRADITIONAL)
ATTN: ALAN  CURTIS                PHONE NO : 650 543 3107   
1810 EMBARCADERO ROAD, SUITE B    SE DECISION MADE: 21-JAN-10
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
SMITH & NEPHEW, INC.              510(k) NO: K092098(TRADITIONAL)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 BROOKS ROAD                  SE DECISION MADE: 22-JAN-10
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
SOPHYSA SA                        510(k) NO: K091328(TRADITIONAL)
ATTN: GUSTAVO  KOBRIN             PHONE NO : 714 508 8048   
8502 E. CHAPMAN AVE SUITE 234     SE DECISION MADE: 22-JAN-10
ORANGE CA 92869                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BTI DENTAL IMPLANT 5.5-6.5
B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K091387(TRADITIONAL)
ATTN: ALFREDO  GOMEZ              PHONE NO : 34 945 297030
LEONARDO DA VINCI 14 B            SE DECISION MADE: 22-JAN-10
MINANO(ALAVA)    SP 01510         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACP4 SPINAL IMPLANT SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K092360(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 22-JAN-10
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC.                 510(k) NO: K092818(TRADITIONAL)
ATTN: ZITA A YURKO                PHONE NO : 724 387 4120   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 22-JAN-10
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAPAROSCOPIC RETRACTORS
CARDINAL HEALTH, INC.             510(k) NO: K092684(TRADITIONAL)
ATTN: SHARON  NICHOLS             PHONE NO : 847 578 6610   
1430  WAUKEGAN ROAD- MPKB-3B      SE DECISION MADE: 22-JAN-10
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM
HEALTH & LIFE CO., LTD.           510(k) NO: K093823(SPECIAL)

ATTN: SARAH  SU                   PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 22-JAN-10
CHUNG HO CITY, TAIPEI    TW 235   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
FOTONA D.D.                       510(k) NO: K093162(TRADITIONAL)ATTN: STOJAN  TROST               PHONE NO : 386 150 09100
STEGNE 7,                         SE DECISION MADE: 22-JAN-10
LJUBLJANA    SI 1210              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METAPHOR METABOLIC MONITOR
TREYMED, INC.                     510(k) NO: K093080(TRADITIONAL)
ATTN: ROBERT H RICCIARDELLI       PHONE NO : 262 820 1294   
N56 W24790 N. CORPORATE CIRCLE UNISE DECISION MADE: 22-JAN-10
SUSSEX WI 53089                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED: NEWDEAL HALLU PLATES
NEWDEAL SAS                       510(k) NO: K093781(SPECIAL)
ATTN: STEPHEN  BEIER              PHONE NO : 609 936 5436   
311 ENTERPRISE DR.                SE DECISION MADE: 22-JAN-10
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OWL UNIVERSAL RF SYSTEM URF-3AP (ML)DIROS TECHNOLOGY, INC.            510(k) NO: K093185(TRADITIONAL)
ATTN: GEORGE  DARMOS              PHONE NO : 905 415 3440
232 HOOD ROAD                     SE DECISION MADE: 22-JAN-10
MARKHAM, ONTARIO    CA L3R 3K8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
SORIN GROUP ITALIA S.R.L.         510(k) NO: K093986(SPECIAL)
ATTN: BARRY  SALL                 PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 22-JAN-10
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOFOAM BONE WEDGE MODEL ASSORTED
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K093950(SPECIAL)
ATTN: KELLEN  HILLS               PHONE NO : 901 290 5816   
5677 AIRLINE RD.                  SE DECISION MADE: 22-JAN-10
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSV II LOW FLOW LOW PRO VALVE
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K093968(SPECIAL)
ATTN: DONNA  MILLISKY             PHONE NO : 609 936 2454   
311 ENTERPRISE DR.                SE DECISION MADE: 22-JAN-10
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
NIPRO MEDICAL CORP.               510(k) NO: K093985(SPECIAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 NW 107TH AVE.                SE DECISION MADE: 22-JAN-10
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K092106(TRADITIONAL)
ATTN: ERICA  LI                   PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 25-JAN-10
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANY PLUS SPINAL FIXATION SYSTEM
GS MEDICAL CO., LTD.              510(k) NO: K091717(TRADITIONAL)
ATTN: WILLIAM F GREENROSE         PHONE NO : 603 369 3550   
220 RIVER ROAD                    SE DECISION MADE: 25-JAN-10
CLAREMONT NH 03743                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGR SURGICAL MESH , MODEL WK-6
NOVUS SCIENTIFIC PTE LTD          510(k) NO: K092224(TRADITIONAL)
ATTN: KELVIN  KOH                 PHONE NO : 656 890 0360
NORDIC EUROPEAN CENTRE, 3 INTERNATSE DECISION MADE: 25-JAN-10
#01-20, SINGAPORE    SN 609927    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLO MICROPUMP INSULIN DELIVERY SYSTEM
MEDINGO LTD.                      510(k) NO: K093364(TRADITIONAL)
ATTN: ARAVA  HACOHEN              PHONE NO : 972 737 131313
YOQNEAM INDUSTRIAL PARK BLDG.7 3RDSE DECISION MADE: 25-JAN-10
YOQNEAM    IS 20692               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDSORB PLUS SCREW SYSTEM
SYNTHES (USA)                     510(k) NO: K093464(TRADITIONAL)
ATTN: JEFFREY  DOW                PHONE NO : 484 356 9720   
1230 WILSON DRIVE                 SE DECISION MADE: 25-JAN-10
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRIND NO MORE GENERATION II
RANIR LLC                         510(k) NO: K094020(SPECIAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 25-JAN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBO-TANDEM SYSTEM MODEL 472-110
SPECTRANETICS CORP.               510(k) NO: K094036(SPECIAL)
ATTN: MICHAEL K HANDLEY           PHONE NO : 719 447 2000   
9665 FEDERAL DRIVE                SE DECISION MADE: 25-JAN-10
COLORADO SPRINGS CO 80921         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPISENS
NOMICS                            510(k) NO: K092845(TRADITIONAL)
ATTN: PIERRE  ANSAY               PHONE NO : 32 437 29348
LIEGE SCIENCE PARK 4 RUE DES CHASSSE DECISION MADE: 26-JAN-10
ANGLEUR, LIEGE    BE 4031         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JALOSKIN
FIDIA ADVANCED BIOPOLYMERS SRL    510(k) NO: K092257(TRADITIONAL)
ATTN: SHARON A SEGAL              PHONE NO : 202 739 3000   
1111 PENNSYLVANIA AVE NW          SE DECISION MADE: 26-JAN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSCAN MICROSTREP PLUS, MODEL B1027-201
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K091949(SPECIAL)

ATTN: SHANNON  POPSON             PHONE NO : 916 374 3330   
1584 ENTERPRISE BLVD              SE DECISION MADE: 26-JAN-10
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
SMITH & NEPHEW, INC.              510(k) NO: K093363(TRADITIONAL)
ATTN: MEGAN  BEVILL               PHONE NO : 901 399 5340   
1450 BROOKS ROAD                  SE DECISION MADE: 26-JAN-10
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
SUNRISE MEDICAL                   510(k) NO: K093070(TRADITIONAL)
ATTN: BETTY LOU  MILLER           PHONE NO : 814 443 7602   
100 DEVILBISS DR.                 SE DECISION MADE: 26-JAN-10
SOMERSET PA 15501                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIDIAN GUIDEWIRE
EV3 NEUROVASCULAR                 510(k) NO: K093681(TRADITIONAL)
ATTN: DEBORAH  BAKER-JANIS        PHONE NO : 949 297 9246   
9775 TOLEDO WAY                   SE DECISION MADE: 26-JAN-10
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRIUM C-QUR OVT MESH
ATRIUM MEDICAL CORP.              510(k) NO: K100076(SPECIAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 603 880 1433   
5 WENTWORTH DR.                   SE DECISION MADE: 26-JAN-10
HUDSON NH 03051                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
RSB SPINE LLC.                    510(k) NO: K092540(SPECIAL)
ATTN: KAREN  WARDEN               PHONE NO : 440 729 8457   
8202  SHERMAN ROAD                SE DECISION MADE: 27-JAN-10
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRVO SERIES HUMIDIFIERS
FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K092846(TRADITIONAL)
ATTN: JAMES  THOMPSON             PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE           SE DECISION MADE: 27-JAN-10
EAST TAMAKI, AUCKLAND    NZ 2013  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
NDD MEDIZITECHNIK AG              510(k) NO: K091428(TRADITIONAL)
ATTN: GERARD  MASIELLO            PHONE NO : 978 470 0923   
TWO DUNDEE PARK                   SE DECISION MADE: 27-JAN-10
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BUTTERFLY TONER MODEL GYM070
GLOBAL MARKETING PARTNERS DBA GYMM510(k) NO: K093368(TRADITIONAL)
ATTN: NICOLAAS  BESSELING         PHONE NO : 949 466 7472   
28711 JAEGER DRIVE                SE DECISION MADE: 27-JAN-10
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHAXENON LIGHT 180 W AND 300 W
GIMMI GMBH                        510(k) NO: K093125(ABBREVIATED)
ATTN: ULRICH  HENZLER             PHONE NO : 497 461 9659030
CARL-ZEISS-STRASSE 6              SE DECISION MADE: 27-JAN-10
TUTTLINGEN    GM D-78532          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD
VICTUS, INC.                      510(k) NO: K093271(TRADITIONAL)
ATTN: ILEANA  YANES               PHONE NO : 305 663 2129   
4918 S.W. 74TH COURT              SE DECISION MADE: 27-JAN-10
MIAMI FL 33155                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SET GRI-FILL 3.0
LABORATORIOS GRIFOLS, S.A.        510(k) NO: K093182(ABBREVIATED)
ATTN: SEBASTIAN  GASCON           PHONE NO : 349 357 10100
 C/CAN GUASCH, 2                  SE DECISION MADE: 27-JAN-10
PARETS DEL VALLES, BARCELONA    SP510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMISE FLOWABLE MODIFIED
KERR CORPORATION                  510(k) NO: K093484(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 27-JAN-10
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IG 4 IMAGE GUIDED SYSTEM
VERAN MEDICAL TECHNOLOGIES, INC.  510(k) NO: K093995(TRADITIONAL)
ATTN: SCOTT  WRIGHTSTONE          PHONE NO : 314 659 8500   
5743 WEST PARK AVE                SE DECISION MADE: 27-JAN-10
ST. LOUIS MO 63110                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY
SHEPHERD SCIENTIFIC INC           510(k) NO: K093822(TRADITIONAL)
ATTN: PAUL  TEIRSTEIN             PHONE NO : 858 554 9905   
1515 COAST WALK                   SE DECISION MADE: 28-JAN-10
LA JOLLA CA 92037                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
STEVE ISLAVA                      510(k) NO: K091794(TRADITIONAL)
ATTN: JIM  BARLEY                 PHONE NO : 949 481 5713   
1599 SUPERIOR AVE, STE B5         SE DECISION MADE: 28-JAN-10
COSTA  MESA CA 92627              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
MEDEFIL, INC.                     510(k) NO: K091583(SPECIAL)
ATTN: PRADEEP  AGGARWAL           PHONE NO : 630 682 4600   
250 WINDY POINT DR.               SE DECISION MADE: 28-JAN-10
GLENDALE HEIGHTS IL 60139         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAKE 1 ADVANCED RIGID TRAY
KERR CORPORATION                  510(k) NO: K092176(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 28-JAN-10
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALEO SPACER SYSTEM
AMEDICA CORP.                     510(k) NO: K091278(TRADITIONAL)
ATTN: ROBERT M WOLFARTH           PHONE NO : 801 583 5100   
615 ARAPEEN DRIVE                 SE DECISION MADE: 28-JAN-10
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
SMITH & NEPHEW, INC.              510(k) NO: K092508(TRADITIONAL)
ATTN: JULIE  ACKER                PHONE NO : 508 261 3618   
150 MINUTEMAN RD.                 SE DECISION MADE: 28-JAN-10
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHOULDER SPEEDER COIL
QUALITY ELECTRODYNAMICS           510(k) NO: K093667(TRADITIONAL)
ATTN: CHRISTIE  ZYDYK             PHONE NO : 440 484 2228   
700 BETA DR. SUITE 100            SE DECISION MADE: 28-JAN-10
MAYFIELD VILLAGE OH 44143         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: UPCERA ZIRCONIA BLANKS
SHENYANG UPCERA CO., LTD.         510(k) NO: K093560(TRADITIONAL)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 28-JAN-10
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
BFW, INC                          510(k) NO: K093386(TRADITIONAL)
ATTN: LYNN  COOPER                PHONE NO : 502 899 1808   
2307 RIVER ROAD SUITE 103         SE DECISION MADE: 28-JAN-10
LOUISVILLE KY 40206               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SR PHONARES NHC
IVOCLAR VIVADENT, INC.            510(k) NO: K093331(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 0010   
175 PINEVIEW DR.                  SE DECISION MADE: 28-JAN-10
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: ATLANTIS SLIT LAMP
USOPTHALMIC, LLC                  510(k) NO: K093021(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305 829 3437   
19526 EAST LAKE DR.               SE DECISION MADE: 28-JAN-10
MIAMI FL 33015 2218               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMOTEX PLATINUM SYSTEM
EAS CONSULTING GROUP LLC          510(k) NO: K092589(TRADITIONAL)
ATTN: EDUARDO  MARCH              PHONE NO : 240 506 3212   
1940 DUKE ST., SUITE 200          SE DECISION MADE: 28-JAN-10
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISSION BREATH ALCOHOL DETECTOR
ACON LABORATORIES, INC.           510(k) NO: K093143(TRADITIONAL)
ATTN: RICHARD  LENART             PHONE NO : 858 875 8019   
10125 MESA RIM RD.                SE DECISION MADE: 28-JAN-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K100067(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 730 5000   
2441 MICHELLE DR                  SE DECISION MADE: 28-JAN-10
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
HOWMEDICA OSTEONICS CORP.         510(k) NO: K093433(SPECIAL)
ATTN: MELISSA A MATARESE          PHONE NO : 201 831 5116   
325 CORPORATE DRIVE               SE DECISION MADE: 28-JAN-10
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URSA ANGIOGRAPHIC CATHETER
CURATIVE MEDICAL TECHNOLOGY, INC. 510(k) NO: K090427(TRADITIONAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
102 MISTLETOE ST.                 SE DECISION MADE: 29-JAN-10
LAKE JACKSON TX 77566             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STATNET, MODEL 3100
HYDRODOT, INC                     510(k) NO: K092828(TRADITIONAL)
ATTN: KATHLEEN  PRINCIPE          PHONE NO : 978 399 0206   
238 LITTLETON ROAD SUITE 202      SE DECISION MADE: 29-JAN-10
WESTFORD MA 01886                 510(k) STATEMENT

DEVICE: TRILOGY 200 VENTILATOR
RESPIRONICS, INC.                 510(k) NO: K093416(TRADITIONAL)
ATTN: ZITA  YURKO                 PHONE NO : 724 387 4120   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 29-JAN-10
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R & D SYSTEMS XERET HEMATOLOGY CONTROL
R & D SYSTEMS, INC.               510(k) NO: K100050(SPECIAL)
ATTN: NANCY  RING                 PHONE NO : 612 656 4533   
614 MCKINLEY PL., N.E.            SE DECISION MADE: 29-JAN-10
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K100117(TRADITIONAL)
ATTN: ZHIGANG  ZHAO               PHONE NO : 867 552 7652471
ESTAE XILIXIAOBAIMANG             SE DECISION MADE: 29-JAN-10
NANSHAN DISTRICT, SHENZHEN    CH 5510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
ANDON HEALTH CO.,LTD              510(k) NO: K100014(SPECIAL)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161
NO 3,  JIN PING STREET NANKAI  DISSE DECISION MADE: 29-JAN-10
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   192                                     
                                                 TOTAL WITH SUMMARIES        173                                     
                                                 TOTAL WITH STATEMENTS        19