January 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2011
DEVICE: ROUGHRIDER
WHIRLWIND WHEELCHAIR INTERNATIONAL510(k) NO: K103212(TRADITIONAL)
ATTN: MARC KRIZACK PHONE NO : 415 338 6277
1600 HOLLOWAY AVENUE SCI 251 SE DECISION MADE: 03-JAN-11
SAN FRANCISCO CA 94132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
DIADEXUS, INC. 510(k) NO: K101853(TRADITIONAL)
ATTN: NINA PELED PHONE NO : 650 246 6486
343 OYSTER POINT BLVD. SE DECISION MADE: 03-JAN-11
SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX-D 100
AGFA HEALTHCARE N.V. 510(k) NO: K103597(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 416 240 7317
10 S ACADEMY STREET SE DECISION MADE: 03-JAN-11
GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 1.5T 16-CHANNEL HAND-WRIST COIL
INVIVO CORPORATION 510(k) NO: K103149(TRADITIONAL)
ATTN: ELIZABETH WHEELER PHONE NO : 352 336 0010
3545 SW 47TH AVE. SE DECISION MADE: 03-JAN-11
GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRYSTALRAD 560 (FLAATZ 560)
MEDICATECH USA 510(k) NO: K102284(TRADITIONAL)
ATTN: JOHN ROSS PHONE NO : 949 679 2881
8870 RAVELLO COURT SE DECISION MADE: 03-JAN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANDA MAX
PHAROS LIFE CORPORATION 510(k) NO: K103415(TRADITIONAL)
ATTN: GORDON WEHNER PHONE NO : 519 651 1177
11-380 JAMIESON PKWY SE DECISION MADE: 03-JAN-11
CAMBRIDGE, ONTARIO CA N3C 4N4 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: I-SEED
THERAGENICS CORP. 510(k) NO: K103319(ABBREVIATED)
ATTN: BESTY CORTELLONI PHONE NO : 770 831 4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 03-JAN-11
BUFORD GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRYSTALRAD (ATAL8)
MEDICATECH USA 510(k) NO: K102285(TRADITIONAL)
ATTN: JOHN ROSS PHONE NO : 949 679 2881
8870 RAVELLO COURT SE DECISION MADE: 03-JAN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER CHAIR FOR KIDS BY ORION
FUTURE MOBILITY HEALTHCARE INC. 510(k) NO: K103073(TRADITIONAL)
ATTN: ABDULSAMAD PANCHBHAYA PHONE NO : 905 671 1661
3223 ORLANDO DRIVE SE DECISION MADE: 03-JAN-11
MISSISSAUGA CA L4V 1C5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F20
TEKNIMED SA 510(k) NO: K103433(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0188
1001 OAKWOOD BLVD SE DECISION MADE: 03-JAN-11
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAROOT IMPLANT SYSTEM
ORAL ICEBERG S.L. 510(k) NO: K093595(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 04-JAN-11
AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADSCAN EQUIPMENT SLICKER
RADSCAN MEDICAL EQUIPMENT, INC. 510(k) NO: K101350(TRADITIONAL)
ATTN: ORAN R BROWN PHONE NO : 623 580 0556
23910 N. 19TH AVE BLDG 2 SUITE SE DECISION MADE: 04-JAN-11
PHOENIX AZ 85085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DUAL INCU I
ATOM MEDICAL CORPORATION 510(k) NO: K102226(TRADITIONAL)
ATTN: TSUYOSHI SUGINO PHONE NO : 813 381 53632
3-18-15 HONGO SE DECISION MADE: 04-JAN-11
BUNKYO-KU, TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
PHILIPS MEDICAL SYSTEMS 510(k) NO: K102974(TRADITIONAL)
ATTN: GARY BECKER PHONE NO : 561 886 5124
6400 N. CONGRESS AVE. SUITE 1050 SE DECISION MADE: 04-JAN-11
BOCA RATON FL 33487 2810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YOBOSHI DENTAL UNIT
FOSHAM YOBOSHI MEDICAL EQUIPMENT C510(k) NO: K103550(TRADITIONAL)
ATTN: SABRINA WEI PHONE NO : 867 558 3089699
ROOM 2706, BLOCK A, ZHONGFANG JINYSE DECISION MADE: 04-JAN-11
SHENZHEN, GUANGDONG CH 528500 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONGRUENT BONE PLATE SYSTEM
ACUMED LLC 510(k) NO: K102998(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503 627 9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 04-JAN-11
HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAUNYING INFRARED LAMP MODEL IL50
FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K101693(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001
11820 RED HIBISCUS DRIVE SE DECISION MADE: 05-JAN-11
BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFIT TOTAL HIP SYSTEM
OTIS BIOTECH CO., LTD 510(k) NO: K101472(ABBREVIATED)
ATTN: SRINIVASAREDDY KROTHA PHONE NO : 82 31 3190406
514, 2-BA BLOCK JEONGWANG-DONG SE DECISION MADE: 05-JAN-11
SIHEUNG-SI, GYOUNGGI-DO KS 429-510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K102544(TRADITIONAL)
ATTN: KATHLEEN SOLOMON PHONE NO : 978 749 1605
130 FORBES BLVD. SE DECISION MADE: 05-JAN-11
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX TIBIAL GRAFTBOLT
ARTHREX, INC. 510(k) NO: K103060(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 05-JAN-11
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
ELLMAN INT'L INC. 510(k) NO: K102698(SPECIAL)
ATTN: JONATHAN ACHENBACH PHONE NO : 763 257 7125
3333 ROYAL AVENUE SE DECISION MADE: 05-JAN-11
OCEANSIDE NY 11572 3625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOBUTTON DIRECT
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K102982(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508 337 4036
150 MINUTEMAN RD. SE DECISION MADE: 05-JAN-11
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 6.0 COCR AND CPT TI-3 RODS
SYNTHES SPINE 510(k) NO: K103287(SPECIAL)
ATTN: ELIZABETH KIERZEK PHONE NO : 610 719 5722
1302 WRIGHTS LANE EAST SE DECISION MADE: 05-JAN-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K103722(TRADITIONAL)
ATTN: PARK KYEONG-MI PHONE NO : 822 219 41381
1003 DAECHI-DONG GANGNAM-GU SE DECISION MADE: 05-JAN-11
SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BUILD-IT TOTAL CORE
PENTRON CLINICAL 510(k) NO: K102703(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 05-JAN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERETENE SOLUBLE IMPLANT MATERIAL
CEREMED, INC. 510(k) NO: K103047(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310 815 2125
3643 LENAWEE AVE. SE DECISION MADE: 05-JAN-11
LOS ANGELES CA 90016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
ALLERGAN MEDICAL 510(k) NO: K102806(SPECIAL)
ATTN: MICAH SCHLOSS PHONE NO : 805 961 5828
71 S. LOS CARNEROS ROAD SE DECISION MADE: 05-JAN-11
GOLETA CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
EV3 INC 510(k) NO: K103618(TRADITIONAL)
ATTN: BRENDA JOHNSON PHONE NO : 763 398 7000
3033 CAMPUS DRIVE SE DECISION MADE: 05-JAN-11
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014" / 0.018" GUIDE WIRE
TRIREME MEDICAL, INC. 510(k) NO: K103534(TRADITIONAL)
ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300
7060 Koll Center Parkway Suite 300SE DECISION MADE: 05-JAN-11
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOMED WOUND CLEANSER
BIOMED LABORATORIES, INC 510(k) NO: K100613(TRADITIONAL)
ATTN: DONALD G WHITE PHONE NO : 972 989 7646
2713 INDUSTRIAL LANE SE DECISION MADE: 05-JAN-11
GARLAND TX 75041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBER SPACER
GLOBUS MEDICAL INC. 510(k) NO: K102293(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610 930 1800
2460 GENERAL ARMISTEAD AVE. SE DECISION MADE: 05-JAN-11
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LTF-Y0009; MAJ-YOO41; XOEV-3D1
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K102379(TRADITIONAL)
ATTN: STACY A KLUESNER, M.S. RAC PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 05-JAN-11
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEANALYER MODEL SAPOC
OPTASIA MEDICAL 510(k) NO: K103475(TRADITIONAL)
ATTN: ANTHONY HOLMES PHONE NO : 011 441 614917860
HAW BANK HOUSE, HIGH STREET SE DECISION MADE: 05-JAN-11
CHEADLE, CHESHIRE UK SK8 1AL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S9 VPAP ST WITH H5I
RESMED LTD. 510(k) NO: K102513(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984
9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 05-JAN-11
KEARNEY MESA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRAL MONITORING SYSTEM
EDAN INSTRUMENTS, INC. 510(k) NO: K100358(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200
1 ODELL PLAZA SE DECISION MADE: 06-JAN-11
YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC. 510(k) NO: K100577(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650 687 5874
1525-B O'BRIEN DR. SE DECISION MADE: 06-JAN-11
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENZ CARDY302 MAX
SUZUKEN CO., LTD. 510(k) NO: K101024(TRADITIONAL)
ATTN: LINDA MORGAN PHONE NO : 972 480 9554
1201 RICHARDSON SUITE 280 SE DECISION MADE: 06-JAN-11
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE GRAPPLR AND GRAPPLR EXTENDER
TAG MEDICAL CORP. 510(k) NO: K101616(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116
291 HILLSIDE AVENUE SE DECISION MADE: 06-JAN-11
SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARVIEW EXACT II INFLUENZA A & B TEST
ALERE SCARBOROUGH, INC D/B/A BINAX510(k) NO: K103610(SPECIAL)
ATTN: ANNE JEPSON PHONE NO : 207 730 5750
10 SOUTHGATE ROAD SE DECISION MADE: 06-JAN-11
SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD NEXIVA CLOSED IV CATHETER SYSTEM
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K102520(SPECIAL)
ATTN: JUSTICE ALDER PHONE NO : 801 565 2662
9450 SOUTH STATE ST. SE DECISION MADE: 06-JAN-11
SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOPOP INFANT RESUSCITATOR WITH FLOW METER
NEOFORCE GROUP, INC. 510(k) NO: K102649(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215 672 6800
35 COMMERCE DR. SE DECISION MADE: 06-JAN-11
IVYLAND PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K103168(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434
49 PLAIN STREET SE DECISION MADE: 06-JAN-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUPRO MODEL 13016901
CAO GROUP, INC. 510(k) NO: K103160(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801 256 9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 06-JAN-11
WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ADDITION
OB THE-ADDITION, LLC 510(k) NO: K102683(TRADITIONAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
2206 MODOC ROAD #3 SE DECISION MADE: 06-JAN-11
SANTA BARBARA CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
OPTI MEDICAL SYSTEMS INC. 510(k) NO: K093280(TRADITIONAL)
ATTN: LEN OWENS PHONE NO : 770 510 4444
235 HEMBREE PARK DRIVE SE DECISION MADE: 07-JAN-11
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
APOLLO SPINE, INC. 510(k) NO: K101588(TRADITIONAL)
ATTN: CHRISTINE SANTAGATE PHONE NO : 781 828 4400
75 MILL STREET SE DECISION MADE: 07-JAN-11
STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON CALL PLUS DIABETES MONITORING SOFTWARE
ACON LABORATORIES, INC. 510(k) NO: K101371(TRADITIONAL)
ATTN: RICHARD LENART PHONE NO : 858 875 8019
10125 MESA RIM RD. SE DECISION MADE: 07-JAN-11
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX SWIVELOCK ANCHORS
ARTHREX, INC. 510(k) NO: K101823(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 07-JAN-11
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS DHEA-S CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO: K103402(TRADITIONAL)
ATTN: KELLY C O'MAINE ADAMS PHONE NO : 317 521 3577
9115 HAGUE ROAD SE DECISION MADE: 07-JAN-11
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE MX40 PATIENT MONITOR
PHILLIPS MEDICAL SYSTEMS 510(k) NO: K103646(SPECIAL)
ATTN: CLAIRE ARAKAKI PHONE NO : 978 659 4348
3000 MINUTEMAN RD. SE DECISION MADE: 07-JAN-11
ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO CATHETER STERILESURE - NEW NAME "PERFIC CATH"
ADAPTA MEDICAL, INC 510(k) NO: K103043(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720 323 1662
4250 GROVE STREET SE DECISION MADE: 07-JAN-11
DENVER CO 80211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6250 ULTRASOUND SYTEMS
ESAOTE, S.P.A. 510(k) NO: K103152(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 07-JAN-11
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
REPROCESSING PRODUCTS CORP. 510(k) NO: K101750(TRADITIONAL)
ATTN: WALLY JANSEN PHONE NO : 763 420 4355
8662 COMSTOCK LN. NORTH SE DECISION MADE: 07-JAN-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
OMNI SURGICAL, L.P. 510(k) NO: K102322(TRADITIONAL)
ATTN: J. D WEBB PHONE NO : 512 388 0199
1001 OAKWOOD BLVD SE DECISION MADE: 07-JAN-11
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACKSTOP CATHETER
PLUROMED, INC. 510(k) NO: K103349(ABBREVIATED)
ATTN: JAMES WILKIE PHONE NO : 781 932 0574
25-H OLYMPIA AVENUE SE DECISION MADE: 07-JAN-11
WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE BLOOD PRESSURE CUFF
WUXI MEDICAL INSTRUMENT FACTORY 510(k) NO: K102823(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
P.O. BOX 237-023 SE DECISION MADE: 07-JAN-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
HOLOGIC, INC. 510(k) NO: K103512(SPECIAL)
ATTN: GAIL YAEKER-DAUNI PHONE NO : 203 731 8337
36 APPLE RIDGE ROAD SE DECISION MADE: 07-JAN-11
DANBURY CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
HOSPIRA, INC. 510(k) NO: K103224(SPECIAL)
ATTN: KAREN KEENER PHONE NO : 224 212 5316
375 NORTH FIELD DR. BLDG. 2 SE DECISION MADE: 07-JAN-11
LAKE FOREST IL 60045 5045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION MP TOTAL KNEE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K102380(SPECIAL)
ATTN: RYAN ROSS PHONE NO : 901 867 4401
5677 AIRLINE RD. SE DECISION MADE: 07-JAN-11
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREEZE C MODEL C (3W), BREEZE C (4W)
AFIKIM ELECTRIC VEHICLES 510(k) NO: K102304(TRADITIONAL)
ATTN: AVNER FISHBEIN PHONE NO : 972 467 54814
KIBBUTZ AFIKIM SE DECISION MADE: 07-JAN-11
KIBBUTZ AFIKIM IS 15148 510(k) STATEMENT
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC. 510(k) NO: K103117(SPECIAL)
ATTN: AMITA S SHAH PHONE NO : 781 345 9164
2 FOURTH AVENUE SE DECISION MADE: 07-JAN-11
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR CONTAIN CAN IMPLANT
POREX SURGICAL, INC. 510(k) NO: K102184(TRADITIONAL)
ATTN: STEPHANIE FULLARD PHONE NO : 678 479 1758
15 DART RD. SE DECISION MADE: 07-JAN-11
NEWNAN GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K102298(TRADITIONAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508 828 3359
325 PARAMOUNT DR. SE DECISION MADE: 07-JAN-11
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMDIA-1000
SOUTHMEDIC, INC. 510(k) NO: K101953(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 07-JAN-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT-ONE SYSTEM
CUSTOM DENTAL IMPLANTS INC 510(k) NO: K102822(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 10-JAN-11
CHESTERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
YU LONG SHENG TECHNOLOGY CO., LTD 510(k) NO: K102508(TRADITIONAL)
ATTN: TONY C CHANG PHONE NO : 886 422 972787
NO. 15, ALLEY 71, CHENPING 1ST BEISE DECISION MADE: 10-JAN-11
TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
NANOSPHERE, INC. 510(k) NO: K103209(TRADITIONAL)
ATTN: GREGORY W SHIPP PHONE NO : 847 400 9000
4088 Commercial Avenue SE DECISION MADE: 10-JAN-11
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFUSE PLUS
ALLOSOURCE, INC. 510(k) NO: K103036(TRADITIONAL)
ATTN: PAMELA VETTER PHONE NO : 720 873 0213
6278 S. TROY CIRCLE SE DECISION MADE: 10-JAN-11
CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
HOSMAN INTERNATIONAL CO., LTD 510(k) NO: K103046(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO 58, FU CHIUN STREET SE DECISION MADE: 10-JAN-11
HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMLOG VARIO SR ABUTMENTS
ALTATEC GMBH 510(k) NO: K103252(TRADITIONAL)
ATTN: LINDA SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 10-JAN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAMAX VERTEBRAL BALLOON
CAREFUSION 510(k) NO: K103064(TRADITIONAL)
ATTN: JOY GREIDANUS PHONE NO : 918 865 4727
1500 WAUKEGAN ROAD SE DECISION MADE: 10-JAN-11
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
AALTO SCIENTIFIC LTD. 510(k) NO: K102617(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922
1959 KELLOGG AVE. SE DECISION MADE: 10-JAN-11
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K103033(TRADITIONAL)
ATTN: KATHLEEN M RUTHERFORD PHONE NO : 973 576 0139
10 POMEROY RD. SE DECISION MADE: 10-JAN-11
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103110(TRADITIONAL)
ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243
26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 10-JAN-11
TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYOSCOPE AND EMBRYOSLIDE
UNISENSE FERTILITECH A/S 510(k) NO: K092183(TRADITIONAL)
ATTN: METTE MUNCH PHONE NO : 45 894 49500
BRENDSTRUPGARDSVEJ 21F SE DECISION MADE: 11-JAN-11
ARRHUS DA DK-8200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HVR PAIN RELIEF DEVICE
H.V.R., INC. 510(k) NO: K101716(TRADITIONAL)
ATTN: JESSANY GARRETT PHONE NO : 808 217 2556
7821 ORION AVE SUITE 200 SE DECISION MADE: 11-JAN-11
VAN NUYS CA 91406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103275(TRADITIONAL)
ATTN: ALICIA BUSTOS-JUERGENSEN PHONE NO : 610 448 4056
51 VALLEY STREAM PKWY. SE DECISION MADE: 11-JAN-11
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
OLYMPUS WINTER & IBE GMBH 510(k) NO: K102781(SPECIAL)
ATTN: STACY ABBATIELLO PHONE NO : 484 896 5405
3500 CORPORATE PKWAY PO BOX 610 SE DECISION MADE: 11-JAN-11
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
B.J.ZH.F. PANTHER MEDICAL EQUIPMEN510(k) NO: K103470(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BLDG. 1 JIANXIANG YU NO.SE DECISION MADE: 11-JAN-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BT-CATH
UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K101535(TRADITIONAL)
ATTN: KEVIN CORNWELL PHONE NO : 801 566 1200
7043 SOUTH 300 WEST SE DECISION MADE: 11-JAN-11
MIDVALE UT 84047 1048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO MED MODEL A102, H104, O101, P103, AND Z100
CARDIO MEDICAL PRODUCTS, INC. 510(k) NO: K103159(TRADITIONAL)
ATTN: NICK MENDISE PHONE NO : 973 586 9500
385 FRANKLIN AVE. STE. L SE DECISION MADE: 11-JAN-11
ROCKAWAY NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
ORIDION CAPNOGRAPHY, INC. 510(k) NO: K101995(TRADITIONAL)
ATTN: RACHEL WEISSBROD PHONE NO :
160 GOULD STREET SE DECISION MADE: 11-JAN-11
NEEDHAM HEIGHTS MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
APOLLO SPINE, INC. 510(k) NO: K102121(TRADITIONAL)
ATTN: CHRISTINE SANTAGATE PHONE NO : 781 828 4400
75 MILL STREET SE DECISION MADE: 12-JAN-11
STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K103645(SPECIAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DR SE DECISION MADE: 12-JAN-11
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIXED MEDIA MARKER
CORTEX MANUFACTURING, INC. 510(k) NO: K102506(TRADITIONAL)
ATTN: ANDREW JONES PHONE NO : 425 334 2277
421 S. DAVIES RD. SE DECISION MADE: 12-JAN-11
LAKE STEVENS WA 98258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTXIDE 50 HS/MS
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K101904(TRADITIONAL)
ATTN: PAOLO PERUZZI PHONE NO : 39 055 8826807
17 VIA BALDANZESE SE DECISION MADE: 12-JAN-11
CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K103365(TRADITIONAL)
ATTN: MICHAEL S PRETO PHONE NO : 330 995 8333
1515 DANNER DR SE DECISION MADE: 12-JAN-11
AURORA OH 44202 9273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K103144(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302
7263 CRONIN CIRCLE SE DECISION MADE: 12-JAN-11
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
G SURGICAL CO., LTD. 510(k) NO: K103070(TRADITIONAL)
ATTN: DONALD GRAFTON PHONE NO : 66 0 27306288
152 SOI RAMKHAMHAENG 138 SAPANSUNGSE DECISION MADE: 12-JAN-11
BANGKOK TH 10240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
KINAMED INCORPORATED 510(k) NO: K102834(SPECIAL)
ATTN: ANTHONY ROSE PHONE NO : 805 384 2748
820 FLYNN ROAD SE DECISION MADE: 12-JAN-11
CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
VARIAN MEDICAL SYSTEMS, ONCOLOGY S510(k) NO: K103394(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731
911 HANSEN WAY SE DECISION MADE: 12-JAN-11
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPECT ENDOSCOPIC ASPIRATION NEEDLE
BOSTON SCIENTIFIC CORP. 510(k) NO: K110030(SPECIAL)
ATTN: ASHLEY PYLE PHONE NO : 508 683 4359
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 12-JAN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ISCREEN VISION SCREENER
ISCREEN VISION, INC. 510(k) NO: K102651(SPECIAL)
ATTN: BUCK BROWN PHONE NO : 901 201 6132
110 TIMBERCREEK DRIVE SUITE# 2 SE DECISION MADE: 12-JAN-11
CORDOVA TN 38018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHSCN PRO
AKERS BIOSCIENCES, INC. 510(k) NO: K102338(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 856 848 8698
201 GROVE RD. SE DECISION MADE: 12-JAN-11
THOROFARE NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSBONE DENTAL
CURASAN AG 510(k) NO: K102872(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 508 643 0434
49 PLAIN STREET SE DECISION MADE: 12-JAN-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
VIEWRAY INCORPORATED 510(k) NO: K102915(TRADITIONAL)
ATTN: JANICE BROWNLEE PHONE NO : 440 703 3210
2 THERMOFISHER WAY SE DECISION MADE: 12-JAN-11
OAKWOOD OH 44146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA CLASS 6 EMULATING INDICATOR
DANA PRODUCTS, INC. 510(k) NO: K100891(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847 455 2881
7 COREY DR. SE DECISION MADE: 13-JAN-11
SOUTH BARINGTON IL 60010 510(k) STATEMENT
DEVICE: PLATELIA ASPERGILLUS EIA MODEL 62793
BIO-RAD 510(k) NO: K093678(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425 881 8300
6565 185TH AVENUE NE SE DECISION MADE: 13-JAN-11
REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
DM SYSTEMS, INCORPORATED 510(k) NO: K101614(TRADITIONAL)
ATTN: MICHAEL ZMUDA PHONE NO : 916 439 2564
1105 BUCHBRUSH DR SE DECISION MADE: 13-JAN-11
FOLSM CA 95630 510(k) STATEMENT
DEVICE: FLEBOSET DOUBLE
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K102590(ABBREVIATED)
ATTN: SEBASTIAN GASCON PHONE NO : 349 357 10100
POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 13-JAN-11
PARETS DEL VALLES, BARCELONA SP510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETAL MONITORS, MODELS F2 AND F3
EDAN INSTRUMENTS, INC. 510(k) NO: K102140(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO :
NANHAI ROAD 1019#, SHEKOU, NANSHENSE DECISION MADE: 13-JAN-11
SHENZHEN, GUANGDONG CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN SPINAL SYSTEM
K2M, INC. 510(k) NO: K103232(SPECIAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 13-JAN-11
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
PHILIPS MEDICAL SYSTESMS 510(k) NO: K103652(SPECIAL)
ATTN: LAWRENCE MILANA PHONE NO : 978 659 7860
300 MINUTEMAN ROAD SE DECISION MADE: 13-JAN-11
ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONASIL A+ IMPRESSION MATERIALS
DMP LTD 510(k) NO: K102836(TRADITIONAL)
ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022 99023041
2ND KM KALYVION AVENUE MARKOPOULO SE DECISION MADE: 13-JAN-11
MARKOPOULO GR 19003 510(k) STATEMENT
DEVICE: SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
A PLUS INTERNATIONAL, INC. 510(k) NO: K102861(TRADITIONAL)
ATTN: SOLOMON CHEN PHONE NO : 909 591 5168
5138 EUCALYPTUS AVE., SE DECISION MADE: 13-JAN-11
CHINO CA 91710 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
MEDIVATORS REPROCESSING SYSTEMS 510(k) NO: K102996(TRADITIONAL)
ATTN: LYNN LUEDERS PHONE NO : 763 553 2475
14605 28TH AVE., NORTH SE DECISION MADE: 13-JAN-11
MINNEAPOLIS MN 55447 4822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
SUMMIT MEDICAL PRODUCTS, INC 510(k) NO: K102460(ABBREVIATED)
ATTN: MARKO VAN AMEN PHONE NO : 801 352 1888
2480 SOUTH MAIN STREET SE DECISION MADE: 13-JAN-11
SALT LAKE CITY UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
HEBEI FAVOR PLASTIC CO., LTD 510(k) NO: K102613(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 13-JAN-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
MEDICA CORP. 510(k) NO: K100829(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 7892
5 OAK PARK DRIVE SE DECISION MADE: 14-JAN-11
BEDFORD MA 01730 510(k) STATEMENT
DEVICE: E1 AVANTAGE HEAD
BIOMET MANUFACTURING CORP. 510(k) NO: K101336(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 800 348 9500
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 14-JAN-11
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
GENX INTL., INC. 510(k) NO: K092963(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203 453 1700
393 SOUNDVIEW RD. SE DECISION MADE: 14-JAN-11
GUILFORD CT 06437 510(k) STATEMENT
DEVICE: SOUNDBITE HEARING SYSTEM BY SONITUS
SONITUS MEDICAL INC 510(k) NO: K100649(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650 593 5225
25 HARTFORD AVE SE DECISION MADE: 14-JAN-11
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV PROTEIN LINEARITY SET
AALTO SCIENTIFIC LTD. 510(k) NO: K101216(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922
1959 KELLOGG AVE. SE DECISION MADE: 14-JAN-11
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
OLYMPUS WINTER & IBE GMBH 510(k) NO: K103032(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY SE DECISION MADE: 14-JAN-11
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
STRYKER CORP. 510(k) NO: K102885(SPECIAL)
ATTN: ZAMIR BAR-DAVID PHONE NO : 201 831 5718
325 CORPORATE DRIVE SE DECISION MADE: 14-JAN-11
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
CODMAN & SHURTLEFF, INC. 510(k) NO: K102589(SPECIAL)
ATTN: SHARON MCDERMOTT PHONE NO : 508 880 8349
325 PARAMOUNT DR. SE DECISION MADE: 14-JAN-11
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
DIAZYME LABORATORIES 510(k) NO: K102432(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 14-JAN-11
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
NAVILYST MEDICAL, INC. 510(k) NO: K103353(SPECIAL)
ATTN: WANDA CARPINELLA PHONE NO : 508 658 7929
26 FOREST STREET SE DECISION MADE: 14-JAN-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORFOLK MEDICAL NORPORT FAMILY OF PORTS
NORFOLK MEDICAL PRODUCTS, INC. 510(k) NO: K102385(TRADITIONAL)
ATTN: MICHAEL J DALTON PHONE NO : 847 674 7075
7350 NORTH RIDGEWAY SE DECISION MADE: 14-JAN-11
SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
GENORAY CO., LTD. 510(k) NO: K103182(TRADITIONAL)
ATTN: JAE KIM PHONE NO : 714 289 8020
1073 N, BATAVIA ST SE DECISION MADE: 14-JAN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED EAR THERMOMETER, MODEL IR-04MT
VEGA TECHNOLOGIES, INC. 510(k) NO: K102934(TRADITIONAL)
ATTN: JOSEPH LU PHONE NO : 886 2 25416996
11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 14-JAN-11
TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
CMA MICRODIALYSIS AB 510(k) NO: K102077(TRADITIONAL)
ATTN: NANCY BLANCO PHONE NO : 978 251 1940
73 PRINCETON STREET SE DECISION MADE: 14-JAN-11
NORTH CHELMSFORD MA 01863 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHWON'S IPL SYSTEM
AHWON MEDI INSTRUMENT CO., LTD 510(k) NO: K102857(TRADITIONAL)
ATTN: YOUNG CHI PHONE NO : 973 278 5222
111 ELLISON STREET SE DECISION MADE: 14-JAN-11
PATERSON NJ 07505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOFLEX ROD
ORTHO-PRO LLC 510(k) NO: K102601(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199
1001 OAKWOOD BLVD SE DECISION MADE: 14-JAN-11
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMC HYPODERMIC NEEDLE
INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K102584(TRADITIONAL)
ATTN: PETER KIM PHONE NO : 847 619 9926
935 N PLUM GROVE RD., STE F SE DECISION MADE: 14-JAN-11
SCHAUMBURG IL 60173 510(k) STATEMENT
DEVICE: 84E SERIES SINGLE PLY WRAPPER
LAC MAC, LTD. 510(k) NO: K102864(TRADITIONAL)
ATTN: JEFFREY O STULL PHONE NO : 512 288 8272
7809 ADELAIDE DR. SE DECISION MADE: 14-JAN-11
AUSTIN TX 78739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-PROX EZ ENDOSCOPIC GRASPER
USGI MEDICAL 510(k) NO: K103688(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949 369 3890
1140 CALLE CORDILLERA SE DECISION MADE: 14-JAN-11
SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING COBRA ANTERIOR CERVICAL PLATE
EMINENT SPINE 510(k) NO: K103068(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 14-JAN-11
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIST FULLY AUTOMATIC BLOOD PRESSURE METER
FUDAKANG INDUSTRIES CO., LTD 510(k) NO: K110013(TRADITIONAL)
ATTN: STEPHEN LING PHONE NO : 867 558 3089699
ROOM 2706 , BLOCK A ZHONGFANG JIN SE DECISION MADE: 14-JAN-11
SHENZHEN, GUANGDON CH 518034 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
ALMA LASERS, INC. 510(k) NO: K103501(SPECIAL)
ATTN: TATIANA EPSTEIN PHONE NO : 224 377 2011
485 HALF DAY RD. SUITE #100 SE DECISION MADE: 14-JAN-11
BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
GIVEN IMAGING LTD. 510(k) NO: K103088(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 972 4 9097936
HERMON BUILDING NEW INDUSTRIAL PARSE DECISION MADE: 14-JAN-11
YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLYTE ELECTROLYTE ANALYZER
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K102959(TRADITIONAL)
ATTN: LIANN VOO PHONE NO : 508 429 0450
333 FISKE ST. SE DECISION MADE: 14-JAN-11
HOLLISTON MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
4-WEB SPINE, LLC 510(k) NO: K083894(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952 431 5999
13540 GUILD AVENUE SE DECISION MADE: 18-JAN-11
APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
SHANGHAI APOLO MEDICAL TECHNOLOGIE510(k) NO: K093627(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592
49 CANDLEWOOD WAY SE DECISION MADE: 18-JAN-11
BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RVT CTO DEVICE
REVASCULAR THERAPEUTICS, INC. 510(k) NO: K101599(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 408 617 0770
766 PALOMAR AVENUE SE DECISION MADE: 18-JAN-11
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN PERIPHERAL GUIDE CATHETER
NEXGEN MEDICAL SYSTEMS, INC. 510(k) NO: K102979(TRADITIONAL)
ATTN: CRAIG PAGAN PHONE NO : 321 728 0126
1050 W. NASA BLVD. SUITE 136 SE DECISION MADE: 18-JAN-11
MELBOURNE FL 32901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO MED
CARDIO MEDICAL PRODUCTS, INC. 510(k) NO: K103334(TRADITIONAL)
ATTN: NICK MENDISE PHONE NO : 973 586 9500
385 FRANKLIN AVE. STE. L SE DECISION MADE: 18-JAN-11
ROCKAWAY NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEPER SYSTEM, EXPEDIUM SYSTEM
DEPUY SPINE, INC. 510(k) NO: K103133(SPECIAL)
ATTN: EUGENE BANG PHONE NO : 508 977 3966
325 PARAMOUNT DR. SE DECISION MADE: 18-JAN-11
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K103469(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434
49 PLAIN STREET SE DECISION MADE: 18-JAN-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WBR XPRESS PET
ULTRASPECT LTD. 510(k) NO: K103710(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 482 46632
6 SIRENI SE DECISION MADE: 19-JAN-11
HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-FIX SPINOUS PROCESS FIXATION PLATE
GLOBUS MEDICAL, INC. 510(k) NO: K102195(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 19-JAN-11
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R3 XLPE ANTEVERTED LINERS
SMITH & NEPHEW, INC. 510(k) NO: K102370(ABBREVIATED)
ATTN: MEGAN BEVILL PHONE NO : 901 399 5340
1450 EAST BROOKS RD. SE DECISION MADE: 19-JAN-11
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IO-FLEX CATHETER
BAXANO, INC. 510(k) NO: K102594(TRADITIONAL)
ATTN: EDWARD J SINCLAIR PHONE NO : 408 514 2220
655 RIVER OAKS PKWY SE DECISION MADE: 19-JAN-11
SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS DIRECT SL II SLITTABLE OUTER CATHETER
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K103250(SPECIAL)
ATTN: COLLEEN CANAN PHONE NO : 818 493 2960
15900 VALLEY VIEW CT. SE DECISION MADE: 19-JAN-11
SYLMAR CA 91342 510(k) STATEMENT
DEVICE: ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K103533(SPECIAL)
ATTN: JULIE GLENDRANGE PHONE NO : 310 533 9966
386 BEECH AVENUE UNIT B6 SE DECISION MADE: 19-JAN-11
TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBOGRAFT VASCULAR PROSTHESIS
LEMAITRE VASCULAR, INC. 510(k) NO: K103080(TRADITIONAL)
ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266
63 2ND AVENUE SE DECISION MADE: 19-JAN-11
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE SALINE SOLUTION
CACHET PHARMACEUTICALS PVT. LTD. 510(k) NO: K102165(TRADITIONAL)
ATTN: SHIVKUMAR AGRAWAL PHONE NO : 919 967 655855
415 SHAH NAHAR, WORLI SE DECISION MADE: 19-JAN-11
MUMBAI IN 400 018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
LUTRONIC CORPORATION 510(k) NO: K100610(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 20-JAN-11
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
GAYMAR INDUSTRIES, INC. 510(k) NO: K100585(TRADITIONAL)
ATTN: BRIAN L ORWAT PHONE NO : 716 662 2551
10 CENTRE DR. SE DECISION MADE: 20-JAN-11
ORCHARD PARK NY 14127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TQ HBA1C GEN3
ROCHE 510(k) NO: K102914(SPECIAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317 521 3831
9115 HAGUE RD SE DECISION MADE: 20-JAN-11
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERALD SPINAL SYSTEM
MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K101446(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5804
1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 20-JAN-11
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K103762(SPECIAL)
ATTN: ROSINA ROBINSON, RN, MED, RPHONE NO : 508 643 0434
49 PLAIN STREET SE DECISION MADE: 20-JAN-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMC COMPOSITE 2
KERR CORPORATION 510(k) NO: K103351(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 20-JAN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERASON T3200 ULTRASOUND SYSTEM
TERATECH CORP. 510(k) NO: K110020(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 206 780 7945
77-79 TERRACE HALL AVE. SE DECISION MADE: 20-JAN-11
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
MIRADOR BIOMEDICAL, INC. 510(k) NO: K103715(SPECIAL)
ATTN: JUSTIN HULVERSHORN PHONE NO : 206 295 3372
2815 WASTLAKE AVENUE SUITE 300 SE DECISION MADE: 20-JAN-11
SEATTLE WA 98102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBIUS ULTRASOUND IMAGING SYSTEM
MOBISANTE, INC. 510(k) NO: K102153(TRADITIONAL)
ATTN: SAILESH CHUTANI PHONE NO : 650 804 5421
14035 NE 85TH COURT SE DECISION MADE: 20-JAN-11
REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCOPRESS SEQUENTIAL DVT PUMP
COMPRESSION THERAPY CONCEPTS 510(k) NO: K102940(SPECIAL)
ATTN: LEONARD NASS PHONE NO : 732 544 0800
35 JAMES WAY SE DECISION MADE: 20-JAN-11
EATONTOWN NJ 07724 510(k) STATEMENT
DEVICE: ELECYSYS SHBG
ROCHE DIAGNOSTICS 510(k) NO: K102814(TRADITIONAL)
ATTN: KELLY FRENCH PHONE NO : 317 521 2458
9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 20-JAN-11
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCP/PC STETHOSCOPE
RNK PRODUCTS, INC. 510(k) NO: K102893(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO PHONE NO : 321 626 7717
4195 US HWY 1 SUITE 101 SE DECISION MADE: 20-JAN-11
ROCKLEDGE FL 32955 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA SYSTEM DUOLITE
QUANTA SYSTEM, S.P.A. 510(k) NO: K103539(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 37679
VIA IV NOVEMBRE,116 SE DECISION MADE: 20-JAN-11
SOLBIATE OLONA(VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
MEDERI THERAPEUTICS INC. 510(k) NO: K103017(TRADITIONAL)
ATTN: CURT RAYMOND PHONE NO : 203 922 0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 20-JAN-11
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
CHEMTRON BIOTECH, INC. 510(k) NO: K102203(TRADITIONAL)
ATTN: JANE ZHANG PHONE NO : 858 530 2868
8370 JUNIPER CREEK LANE SUITE 1-2 SE DECISION MADE: 20-JAN-11
SAN DIEGO CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
ORTHO SOLUTIONS LIMITED 510(k) NO: K102743(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858
3150 EAST 200TH STREET SE DECISION MADE: 20-JAN-11
PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K103468(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434
49 PLAIN STREET SE DECISION MADE: 20-JAN-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSAVER
OCULAR SYSTEMS, INC. 510(k) NO: K090626(TRADITIONAL)
ATTN: KURT WEBER PHONE NO : 336 784 4603
101 N CHESTNUT STREET SUITE 301 SE DECISION MADE: 21-JAN-11
WINSTON-SALEM NC 27101 510(k) STATEMENT
DEVICE: LIPOCONTROL
OSYRIS MEDICAL 510(k) NO: K090754(TRADITIONAL)
ATTN: BLANDINE BOUVET PHONE NO : 33 3 20679044
60 AVENUE HALLEY F59650 VILLENEUVESE DECISION MADE: 21-JAN-11
FRANCE FR F59650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGO 4S
DIAMEDIX CORP. 510(k) NO: K093101(TRADITIONAL)
ATTN: GLENN GERSTENFELD PHONE NO : 305 324 2314
2140 NORTH MIAMI AVE. SE DECISION MADE: 21-JAN-11
MIAMI FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
ALMA LASERS, INC. 510(k) NO: K101147(TRADITIONAL)
ATTN: TATIANA EPSTEIN PHONE NO : 224 377 2011
485 HALF DAY RD. SUITE #100 SE DECISION MADE: 21-JAN-11
BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
PACIFIC CONSOLIDATED INDUSTRIES, L510(k) NO: K100957(TRADITIONAL)
ATTN: GARY CLARK PHONE NO : 951 479 0872
12201 MAGNOLIA AVE. SE DECISION MADE: 21-JAN-11
RIVERSIDE CA 92503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETCH 2 ASPIRATION CATHETER MODEL 109400-001
MEDRAD INTERVENTIONAL/POSSIS 510(k) NO: K101354(TRADITIONAL)
ATTN: DOUG ATKINS PHONE NO : 763 780 4555
9055 EVERGREEN BLVD NW SE DECISION MADE: 21-JAN-11
MINNEAPOLIS MN 55433 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
3M ESPE DENTAL PRODUCTS 510(k) NO: K110131(TRADITIONAL)
ATTN: GINGER CANTOR PHONE NO : 651 733 1317
3M CENTER, BUILDING 260-2A-11 SE DECISION MADE: 21-JAN-11
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
SYNTHES (USA) 510(k) NO: K103243(TRADITIONAL)
ATTN: CHRISTOPHER HACK PHONE NO : 610 719 6940
1301 GOSHEN PKWY. SE DECISION MADE: 21-JAN-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFA WARMER I
ATOM MEDICAL CORPORATION 510(k) NO: K102227(TRADITIONAL)
ATTN: TSUYOSHI SUGINO PHONE NO : 813 381 53632
3-18-15 HONGO SE DECISION MADE: 21-JAN-11
BUNKYO-KU, TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOW ADHERENT AFM AG DRESSINGS
MILLIKEN HEALTHCARE PRODUCTS, LLC 510(k) NO: K103141(SPECIAL)
ATTN: RONALD S WARREN, RAC PHONE NO : 858 753 1961
11440 W. BERNARDO COURT SUITE 300 SE DECISION MADE: 21-JAN-11
SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REALEYE MODEL VCPS
NAVOTEK MEDICAL LTD 510(k) NO: K100625(TRADITIONAL)
ATTN: STEVEN B DATLOF, M.D., J.D. PHONE NO : 267 675 4613
1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 21-JAN-11
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPERLOC COMPLETE, SIZE 5 AND 6
BIOMET MANUFACTURING CORP. 510(k) NO: K103755(SPECIAL)
ATTN: BECKY EARL PHONE NO : 574 267 6639
PO BOX 587 SE DECISION MADE: 21-JAN-11
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
BIOREMEDI THERAPEUTIC SYSTEMS, INC510(k) NO: K101894(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301 279 2899
9109 COPENHAVER DRIVE SE DECISION MADE: 21-JAN-11
POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
BIOSENSE WEBSTER, INC. 510(k) NO: K103746(SPECIAL)
ATTN: WAYNE R HOHMAN PHONE NO : 909 839 8597
3333 DIAMOND CANYON RD. SE DECISION MADE: 21-JAN-11
DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
THE LAGADO CORP. 510(k) NO: K102154(TRADITIONAL)
ATTN: JOHN M SZABOCISK PHONE NO : 312 553 0828
203 NORTH WABASH, STE 2208 SE DECISION MADE: 21-JAN-11
CHICAGO IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
EXACTECH, INC. 510(k) NO: K102870(TRADITIONAL)
ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 21-JAN-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-C2
HAMILTON MEDICAL AG 510(k) NO: K102775(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 81 6606010
VIA CRUSCH 8 SE DECISION MADE: 21-JAN-11
BONADUZ SZ CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON XL ANALYZER MODEL 10050
DIASORIN, INC. 510(k) NO: K103529(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651 351 5635
195 NORTHWESTERN AVE. P.O. BOX 285SE DECISION MADE: 21-JAN-11
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRANDIO SO FLOW
VOCO GMBH 510(k) NO: K103580(SPECIAL)
ATTN: MANFRED THOMAS PLAUMANN PHONE NO : 494 721 7190
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 21-JAN-11
CUXHAVEN GM D-27472 510(k) STATEMENT
DEVICE: COMPACT PIEZO P2K, POWERCARE
MECTRON S.P.A. 510(k) NO: K102218(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 390 657 82665
PIAZZA ALBANIA 10 SE DECISION MADE: 24-JAN-11
ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUND PRO APEX
ACCURO MEDICAL PRODUCTS LLC 510(k) NO: K100823(TRADITIONAL)
ATTN: TODD HUBBARD PHONE NO : 630 829 1675
3879 EAST 120TH AVE SUITE 328 SE DECISION MADE: 24-JAN-11
DENVER CO 80233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORBACT
ABIGO MEDICAL AB 510(k) NO: K100591(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 763 574 1976
435 RICE CREEK TERRACE NE, SE DECISION MADE: 24-JAN-11
FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
VASCULAR SOLUTIONS, INC. 510(k) NO: K101604(TRADITIONAL)
ATTN: JENNIFER RUETHER PHONE NO : 763 656 4300
6464 SYCAMORE COURT SE DECISION MADE: 24-JAN-11
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYPHON INFLATION SYRINGE
MEDTRONIC SPINE LLC 510(k) NO: K103231(TRADITIONAL)
ATTN: HETAL JAWAHAR THAKKER PHONE NO : 408 548 6500
1221 CROSSMAN AVE. SE DECISION MADE: 24-JAN-11
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIZION DR
VIZTEK, INC. 510(k) NO: K102123(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 24-JAN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
ANGSTROM MFG., INC. 510(k) NO: K103157(TRADITIONAL)
ATTN: CHRIS CARRON PHONE NO : 573 483 3773
6539 U.S. HWY. 61 SE DECISION MADE: 24-JAN-11
BLOOMSDALE MO 63627 510(k) STATEMENT
DEVICE: RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K102336(TRADITIONAL)
ATTN: ASHLEY PYLE PHONE NO : 508 683 4359
2546 FIRST STREET, PROPARK SE DECISION MADE: 24-JAN-11
ALAJUELA CS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL SHOULDER SYSTEM
SHOULDER INNOVATIONS, LLC 510(k) NO: K102670(TRADITIONAL)
ATTN: ANDREW RODENHOUSE PHONE NO : 616 706 3903
4670 FULTON STREET EAST SUITE 202 SE DECISION MADE: 24-JAN-11
ADA MI 49301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS ULNA PLATES
MEDARTIS AG 510(k) NO: K103332(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 24-JAN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K103450(TRADITIONAL)
ATTN: KENT PRUETT PHONE NO : 830 372 1391
940 CROSSROADS BLVD. SE DECISION MADE: 25-JAN-11
SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUORCANASITE DENTAL CERAMIC
DR SARAH POLLINGTON 510(k) NO: K100794(TRADITIONAL)
ATTN: JUDY BURTON PHONE NO : 972 243 5105
3010 LBJ FRWY 12TH FLOOR SE DECISION MADE: 25-JAN-11
DALLAS TX 75234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL FLUID PHENCYCLIDINE
ROCHE DIAGNOSTICS 510(k) NO: K093989(TRADITIONAL)
ATTN: MICHELLE LEE NEFF PHONE NO : 317 521 2000
9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 25-JAN-11
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURECALL EMG LABOR MONITOR
REPRODUCTIVE RESEARCH TECHNOLOGIES510(k) NO: K090145(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713 723 4080
11874 SOUTH EVELYN SE DECISION MADE: 25-JAN-11
HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOVITA PEEK SPACER
ORTHOVITA, INC. 510(k) NO: K101171(TRADITIONAL)
ATTN: CATHERINE V MOFFA PHONE NO : 610 640 1775
45 GREAT VALLEY PKWY. SE DECISION MADE: 25-JAN-11
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEROX, MODEL 321OF
OR-NIM MEDICAL LTD. 510(k) NO: K100875(TRADITIONAL)
ATTN: MICHAL BALBERG PHONE NO : 972 892 82801
1 YODFAT ST SE DECISION MADE: 25-JAN-11
LOD IS 71291 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIATRON PICTUS 400
DIATRON GROUP 510(k) NO: K101741(TRADITIONAL)
ATTN: JIM SCHEPP PHONE NO : 954 614 8493
2545 MONTCLAIRE CIRCLE SE DECISION MADE: 25-JAN-11
WESTO FL 33327 510(k) STATEMENT
DEVICE: ORTHODONTIC CERAMIC BRACKET
HT CO., LTD. 510(k) NO: K102561(TRADITIONAL)
ATTN: JERRY CHOI PHONE NO : 823 140 03932
HBI 527, HANYANG UNIV. 1271 SA 1(ISE DECISION MADE: 25-JAN-11
ANSAN-SI, GYEONGGI-DO KS 426-79510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSC LIPID CONTROL
MAINE STANDARDS CO. 510(k) NO: K103271(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207 892 1300
765 ROOSEVELT TRAIL SE DECISION MADE: 25-JAN-11
WINDHAM ME 04062 5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K103616(TRADITIONAL)
ATTN: TONY SPACCAROTELLA PHONE NO : 845 268 0101
360 NORTH ROUTE 9W SE DECISION MADE: 25-JAN-11
CONGERS NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISA ENZ 2 CAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K103612(TRADITIONAL)
ATTN: ANNA MARIE K ENNIS PHONE NO : 302 631 9352
500 GBC DRIVE P.O. BOX 6101 SE DECISION MADE: 25-JAN-11
NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER FLAT SURGICAL MASK
TIGER MEDICAL PRODUCTS LTD 510(k) NO: K102713(ABBREVIATED)
ATTN: MAGGIE ZHONG PHONE NO : 862 133 907930
LIULIN TOWER, STE 1910, 1 HUAI HAISE DECISION MADE: 25-JAN-11
SHANGHAI CH 200021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
PROMIMIC AB 510(k) NO: K101225(TRADITIONAL)
ATTN: KARIN BREDING PHONE NO : 463 177 28035
STENA CENTER 1B SE DECISION MADE: 25-JAN-11
GOTEBORG SW SE-412 92 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITECURE THERAPY SYSTEM
LITECURE, LLC 510(k) NO: K103511(SPECIAL)
ATTN: LIANG LU PHONE NO : 302 709 0408
250 CORPORATE BLVD., SUITE B SE DECISION MADE: 25-JAN-11
NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEETAH RELIANT
CHEETAH MEDICAL INC. 510(k) NO: K103166(ABBREVIATED)
ATTN: RHONA SHANKER PHONE NO : 301 251 9570
12154 DARNESTOWN RD. #236 SE DECISION MADE: 25-JAN-11
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAMENCO SPINAL FIXATION SYSTEM
ULRICH GMBH & CO. KG 510(k) NO: K102853(TRADITIONAL)
ATTN: HANS STOVER PHONE NO : 636 519 0268
754 SPIRIT 40 PARK DRIVE SE DECISION MADE: 25-JAN-11
CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
MEDICAL WIRE & EQUIPMENT COMPANY (510(k) NO: K103805(SPECIAL)
ATTN: DAVID ELLIS PHONE NO : 441 225 810361
POTLEY LANE SE DECISION MADE: 25-JAN-11
CORSHAM, WILTSHIRE UK SN13 9RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-STATION
PHILIPS ULTRASOUND, INC. 510(k) NO: K103815(TRADITIONAL)
ATTN: NANCY P BURKE PHONE NO : 425 487 7371
P.O. BOX 3003 SE DECISION MADE: 25-JAN-11
BOTHELL WA 98021 3003 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KOWA NONMYD WX
KOWA CO. LTD. 510(k) NO: K101628(TRADITIONAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : 813 327 97646
4-14, NIHONBASHI-HONCHO 3-CHOME SE DECISION MADE: 26-JAN-11
CHUO-KU, TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERSR ELECTROMYOGRAPHY SYSTEM
SPINEMATRIX, INC. 510(k) NO: K110048(SPECIAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 26-JAN-11
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS 510(k) NO: K110004(SPECIAL)
ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794
355 THIRTEENTH STREET, NW SE DECISION MADE: 26-JAN-11
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE BLOOD PRESSURE CUF
CAREMATE MEDICAL DEVICE CO., LTD 510(k) NO: K102792(TRADITIONAL)
ATTN: LEE FU PHONE NO : 86 21 64264467
P.O. BOX 237-023 SE DECISION MADE: 26-JAN-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
KAZ USA, INC (A SUBSIDIARY OF KAZ 510(k) NO: K103800(SPECIAL)
ATTN: RAJ KASBEKAR PHONE NO : 508 490 7280
250 TURNPIKE ROAD SE DECISION MADE: 26-JAN-11
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAYHEALTHY BODY COMPOSITION MONITOR-BCM
STAYHEALTHY, INC. 510(k) NO: K101807(TRADITIONAL)
ATTN: JESUS FARINAS PHONE NO : 626 256 6152
724 E. HUNTINGTON DRIVE SE DECISION MADE: 26-JAN-11
MONROVIA CA 91016 510(k) STATEMENT
DEVICE: CONSENSUS KNEE SYSTEM
CONSENSUS ORTHOPEDICS, INC 510(k) NO: K102927(TRADITIONAL)
ATTN: MATTHEW HULL PHONE NO : 916 355 7100
1115 WINFIELD WAY SUITE 100 SE DECISION MADE: 26-JAN-11
EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREQUENCER
DYMEDSO INC. 510(k) NO: K103176(TRADITIONAL)
ATTN: JEAN BIGONEY PHONE NO : 802 885 8026
127 MAIN ST. PO BOX 826 SE DECISION MADE: 26-JAN-11
SPRINGFIELD VT 05156 0826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE VIEW SYSTEM
ST. JUDE MEDICAL 510(k) NO: K110085(TRADITIONAL)
ATTN: KRIS MILLER PHONE NO :
ONE ST JUDE MEDICAL DRIVE SE DECISION MADE: 26-JAN-11
ST PAUL MN 55117 9913 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODEL LTV 1100 VENTILATOR
CAREFUSION 510(k) NO: K101643(TRADITIONAL)
ATTN: MONTHER ABUSHABAN PHONE NO : 714 919 3660
22745 SAVI RANCH PARKWAY SE DECISION MADE: 26-JAN-11
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K101945(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 26-JAN-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
SURGIVISION, INC. 510(k) NO: K102101(TRADITIONAL)
ATTN: EDWARD WADDELL PHONE NO : 949 900 6833
5 MUSICK SE DECISION MADE: 26-JAN-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K102886(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 26-JAN-11
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K103780(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408 433 1428
821 FOX LANE SE DECISION MADE: 26-JAN-11
SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENUMBRA EMBOLIZATION COIL SYSTEM
PENUMBRA, INC. 510(k) NO: K103305(TRADITIONAL)
ATTN: SETH A SCHULMAN PHONE NO : 510 748 3200
1351 HARBOR BAY PARKWAY SE DECISION MADE: 26-JAN-11
ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEFORTE NEURO SYSTEM BONE PLATE
JEIL MEDICAL CORPORATION 510(k) NO: K103778(SPECIAL)
ATTN: PAUL SUMNER PHONE NO : 770 448 7529
5966 EXETER CIRCLE SE DECISION MADE: 26-JAN-11
NORCROSS GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIVISION
MODERN MODULE INC 510(k) NO: K110040(TRADITIONAL)
ATTN: SAMUEL KOH PHONE NO : 823 262 36721
425 CHEONGCHUN-DONG, BUPYUNG-KU SE DECISION MADE: 26-JAN-11
LNCHEON KS 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
WILDCAT MEDICAL INC 510(k) NO: K103187(TRADITIONAL)
ATTN: JOE ADKINS PHONE NO : 216 849 7847
284 RIDGE ROAD SE DECISION MADE: 26-JAN-11
HINCKLEY OH 44233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEDECAL
SEDECAL S.A. 510(k) NO: K103522(SPECIAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO SE DECISION MADE: 26-JAN-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUID FILLED TEETHER - GEL
KIDS II 510(k) NO: K092025(ABBREVIATED)
ATTN: BOB COUGHLIN PHONE NO : 770 751 0442
555 NORTH POINT CENTER SUITE 600 SE DECISION MADE: 27-JAN-11
ALPHARETTA GA 30022 510(k) STATEMENT
DEVICE: VENTLAB 6000 SERIES HUMIDIFIER
VENTLAB CORP. 510(k) NO: K093617(TRADITIONAL)
ATTN: JAMES A COCHIE PHONE NO : 336 753 5000
155 BOYCE DRIVE SE DECISION MADE: 27-JAN-11
MOCKSVILLE NC 27028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC ORAL MOISTURIZING GEL
GC AMERICA, INC. 510(k) NO: K101346(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 897 4042
3737 W. 127TH ST. SE DECISION MADE: 27-JAN-11
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
SMITH & NEPHEW, INC. 510(k) NO: K101459(TRADITIONAL)
ATTN: JULIE ACKER PHONE NO : 978 749 1000
150 MINUTEMAN RD. SE DECISION MADE: 27-JAN-11
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
SPS MEDICAL SUPPLY CORP. 510(k) NO: K102363(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585 359 0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 27-JAN-11
RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
SYNTHES USA PRODUCTS LLC 510(k) NO: K102722(TRADITIONAL)
ATTN: JEFFREY L DOW, JD PHONE NO : 484 356 9720
1230 WILSON DRIVE SE DECISION MADE: 27-JAN-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDONDO-L
SEASPINE, INC. 510(k) NO: K103297(SPECIAL)
ATTN: ETHEL BERNAL PHONE NO : 760 727 8399
2302 LA MIRADA DR. SE DECISION MADE: 27-JAN-11
VISTA CA 92081 7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4D MV-ASSESSMENT 2.0
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K103782(SPECIAL)
ATTN: INGE SCHEIDT PHONE NO : 498 932 175515
EDISONSTRASSE 6 SE DECISION MADE: 27-JAN-11
UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISIO CHAMBER SPACE
KOO(SHANGHAI)INDUSTRIES CO., LTD. 510(k) NO: K101136(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 28-JAN-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
LIMA-LTO S.P.A. 510(k) NO: K101263(TRADITIONAL)
ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220
PO BOX 696 SE DECISION MADE: 28-JAN-11
WINONA LAKE IN 46590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMAPRINT
AGENDIA 510(k) NO: K101454(TRADITIONAL)
ATTN: GUIDO BRINK PHONE NO :
SCIENCE PARK 406 SE DECISION MADE: 28-JAN-11
AMSTERDAM NL 1098SM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMA SCREEN ER
IMMUNOSTICS, INC. 510(k) NO: K102664(SPECIAL)
ATTN: RICHARD M PEOPLES PHONE NO : 732 918 0770
3505 SUNSET AVE. SE DECISION MADE: 28-JAN-11
OCEAN NJ 07712 510(k) STATEMENT
DEVICE: NEUCOLONCARE
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K110077(TRADITIONAL)
ATTN: TIAN YEUHUI PHONE NO : 862 483 660646
NO. 16, SHIJI ROAD HUNNAN INDUSRTISE DECISION MADE: 28-JAN-11
SHENYANG, LIAONING CH 110179 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
AMBU A/S 510(k) NO: K102824(ABBREVIATED)
ATTN: SANJAY PARIKH PHONE NO : 410 768 6464
6740 BAYMEADOW DR. SE DECISION MADE: 28-JAN-11
GLEN BURNIE MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTICARE PILLSTATION
SENTICARE, INC. 510(k) NO: K103009(TRADITIONAL)
ATTN: SETH A MAILHOT PHONE NO : 202 585 8196
401 9TH STREET NW SUITE 900 SE DECISION MADE: 28-JAN-11
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRADRY SYSTEM
MIRAMAR LABS, INC. 510(k) NO: K103014(TRADITIONAL)
ATTN: KATHY O'SHAUGHNESSY PHONE NO : 408 940 8700
445 INDIO WAY SE DECISION MADE: 28-JAN-11
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANS SYSTEM
CAIRD TECHNOLOGY 510(k) NO: K101016(TRADITIONAL)
ATTN: JAMES H BROWN PHONE NO : 802 237 8175
205 CAMDEN CHASE SE DECISION MADE: 28-JAN-11
COLUMBIA SC 29223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K102884(TRADITIONAL)
ATTN: KEVIN CORRIGAN PHONE NO : 949 453 6410
33 TECHNOLOGY DR. SE DECISION MADE: 28-JAN-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLSTICE
KERR CORPORATION 510(k) NO: K102621(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 28-JAN-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
WON INDUSTRIAL CO. 510(k) NO: K102319(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592
49 CANDLEWOOD WAY SE DECISION MADE: 28-JAN-11
BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K103677(TRADITIONAL)
ATTN: ZHAI PEI PHONE NO : 867 552 6582551
BLDG.A3,HONG HUA LING IND.PARK NORSE DECISION MADE: 31-JAN-11
NANSHAN,SHENZHEN, GUANGDONG CH 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COR ANALYZER
RCADIA MEDICAL IMAGING LTD. 510(k) NO: K110071(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 4 8246632
6 SIRENI SE DECISION MADE: 31-JAN-11
HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
COLOPLAST A/S 510(k) NO: K103254(TRADITIONAL)
ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987
1601 WEST RIVER ROAD NORTH SE DECISION MADE: 31-JAN-11
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW SMF HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K103256(ABBREVIATED)
ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161
1450 EAST BROOKS RD. SE DECISION MADE: 31-JAN-11
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA SYNCHRO FT
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K103288(TRADITIONAL)
ATTN: PAOLO PERUZZI PHONE NO : 390 558 826807
17 VIA BALDANZESE SE DECISION MADE: 31-JAN-11
CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
ENCORE MEDICAL, L.P. 510(k) NO: K103208(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255
9800 METRIC BLVD. SE DECISION MADE: 31-JAN-11
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO COMPOSITE NAILING SYSTEM
N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K102369(TRADITIONAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET SE DECISION MADE: 31-JAN-11
HARZELIYA IS 46724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
TORNIER, INC. 510(k) NO: K102924(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997
100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 31-JAN-11
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAPSE 3D CARDIAC TOOLS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K103465(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774
419 WEST AVE. SE DECISION MADE: 31-JAN-11
STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 259
TOTAL WITH SUMMARIES 242
TOTAL WITH STATEMENTS 17
