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Medical Devices
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April 2005 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-APR-2005 THROUGH 30-APR-2005
DEVICE: AXS-1 LITE WHEELCHAIR
ACCESS POINT MEDICAL, L.L.C. 510(k) NO: K050279(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 11-APR-05
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUNABOUT WHEELCHAIR
ACCESS POINT MEDICAL, L.L.C. 510(k) NO: K050280(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 11-APR-05
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSPORT SERIES TRANSPORT CHAIR
ACCESS POINT MEDICAL, L.L.C. 510(k) NO: K050281(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 11-APR-05
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTE
ACTIVE OPTICAL SYSTEMS, LTD. 510(k) NO: K050950(TRADITIONAL)
ATTN: EFRAIM BIDAS PHONE NO : 972 393 41682
24 HERZEL ST. SE DECISION MADE: 29-APR-05
PETACH TIKVA, ISRAEL 49591 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICROLUX DL
ADDENT, INC. 510(k) NO: K041614(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN PHONE NO : 203-778-0200
43 MIRY BROOK RD. SE DECISION MADE: 04-APR-05
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPLETE MOISTUREPLUS MULTI-PURPOSE SOLUTION
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K050494(ABBREVIATED)
ATTN: PETER XU PHONE NO : 714-247-8592
1700 E. ST. ANDREW PLACE SE DECISION MADE: 13-APR-05
P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92799-5162
DEVICE: SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K050648(TRADITIONAL)
ATTN: PAM SCHAUB PHONE NO : 714-247-8603
1700 EAST ST. ANDREW PL. SE DECISION MADE: 05-APR-05
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAL CABLE RETENTION CLIP
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K050633(SPECIAL)
ATTN: RASHMI MOZA PHONE NO : 972-309-8055
6901 PRESTON RD. SE DECISION MADE: 21-APR-05
PLANO, TX 75024 510(k) STATEMENT
DEVICE: CIDEX OPA CONCENTRATE
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K032959(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-789-3838
33 TECHNOLOGY DR. SE DECISION MADE: 04-APR-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD NX STERILIZER
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K042116(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482
33 TECHNOLOGY DR. SE DECISION MADE: 22-APR-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP ORTHOPILOT 2 THA V 2.0
AESCULAP, INC. 510(k) NO: K050752(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 27-APR-05
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K050804(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 11-APR-05
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIP INTENSE PULSED LIGHT SYSTEM
AESTHERA CORPORATION 510(k) NO: K041554(TRADITIONAL)
ATTN: C. ROBERT PAYNE PHONE NO : 408-782-3024
P.O. BOX 2608 SE DECISION MADE: 27-APR-05
MORGAN HILL, CA 95038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
AGFA CORP. 510(k) NO: K050751(SPECIAL)
ATTN: PHIL CUSCUNA PHONE NO : 519-572-9339
10 SOUTH ACADEMY ST. SE DECISION MADE: 21-APR-05
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGFA CR50.0
AGFA CORP. 510(k) NO: K050810(SPECIAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 21-APR-05
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEL VBR SPINAL SYSTEM
ALPHATEC/NEXMED 510(k) NO: K050553(SPECIAL)
ATTN: ELLEN A YARNALL PHONE NO : 760-431-9286
6110 CORTE DEL CEDRO SE DECISION MADE: 18-APR-05
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/0
AMEDICA CORP. 510(k) NO: K050699(SPECIAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 801-583-5100
615 ARAPEEN DRIVE SE DECISION MADE: 15-APR-05
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84108
DEVICE: EASYGLUCO IGM-0002 G2
AMERICAN HEALTHCARE INC. 510(k) NO: K043512(TRADITIONAL)
ATTN: EDWARD LETKO PHONE NO : 866-216-5308
304 PARK AVENUE SOUTH SE DECISION MADE: 08-APR-05
SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10010-4301
DEVICE: BLOOD GLUCOSE MONITORING SYSTEM
AMERICAN HEALTHCARE INC. 510(k) NO: K043543(TRADITIONAL)
ATTN: EDWARD LETKO PHONE NO : 866-216-5308
304 PARK AVENUE SOUTH SE DECISION MADE: 08-APR-05
SUITE 218 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10010-4301
DEVICE: APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
APPLE MEDICAL CORP. 510(k) NO: K050256(TRADITIONAL)
ATTN: JAMES DELANEY PHONE NO : 617-482-4004
75 FEDERAL STREET, 9TH FL SE DECISION MADE: 26-APR-05
BOSTON, MA 02110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIOL HER-2/NEU FISH
APPLIED IMAGING CORP. 510(k) NO: K043519(TRADITIONAL)
ATTN: DIANE C DAY PHONE NO : 408-719-6428
120 BAYTECH DRIVE SE DECISION MADE: 25-APR-05
SAN JOSE, CA 95134-2302 510(k) STATEMENT
DEVICE: SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
ARKRAY, INC. 510(k) NO: K050652(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7363
510 FURNACE DOCK RD. SE DECISION MADE: 06-APR-05
CORTLANDT MANOR, NY 10567 510(k) STATEMENT
DEVICE: ARTHERX CORKSCREW FT II SUTURE ANCHOR
ARTHREX, INC. 510(k) NO: K050358(SPECIAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 15-APR-05
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
AXIS-SHIELD LTD. 510(k) NO: K042411(TRADITIONAL)
ATTN: SUSAN LEONARD PHONE NO : 440 138 2422000
THE TECHNOLOGY PARK SE DECISION MADE: 07-APR-05
DUNDEE, TAYSIDE, SCOTLAND, UNITED 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
AXON SYSTEMS, INC. 510(k) NO: K050194(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 26-APR-05
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDPORT TITANIUM PORTS
BARD ACCESS SYSTEMS, INC. 510(k) NO: K050310(SPECIAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700
5425 WEST AMELIA EARNHART DR. SE DECISION MADE: 18-APR-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
BAUSCH & LOMB, INC. 510(k) NO: K050157(TRADITIONAL)
ATTN: LISA GRANEY PHONE NO : 585-338-6612
1400 N. GOODMAN STREET SE DECISION MADE: 26-APR-05
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
BAYER HEALTHCARE, LLC 510(k) NO: K043228(TRADITIONAL)
ATTN: CAROL BIANCA PHONE NO : 914-524-2531
511 BENEDICT AVE. SE DECISION MADE: 22-APR-05
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD POSIFLOW POSITIVE DISPLACEMENT VALVE
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K050207(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 07-APR-05
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 U
BECTON, DICKINSON & CO. 510(k) NO: K050555(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 14-APR-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0
BECTON, DICKINSON & CO. 510(k) NO: K050745(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 29-APR-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0
BECTON, DICKINSON & CO. 510(k) NO: K050747(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 29-APR-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G,
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K050666(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500
901 GRAYSON ST., SUITE 101 SE DECISION MADE: 11-APR-05
BERKELEY, CA 94710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICON ORTHODONTIC IMPLANT SYSTEM
BICON, INC. 510(k) NO: K050408(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443
501 ARBORWAY SE DECISION MADE: 07-APR-05
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
BICON, INC. 510(k) NO: K050712(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-390-4363
501 ARBORWAY SE DECISION MADE: 22-APR-05
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKER
BIO-RAD 510(k) NO: K050537(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949-598-1467
9500 JERONIMO RD. SE DECISION MADE: 27-APR-05
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
BIO-RAD LABORATORIES, INC. 510(k) NO: K050682(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 29-APR-05
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTIA LA(A)
BIOKIT S.A. 510(k) NO: K050487(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 349 386 09000
CAN MALE LLISSA D'AMUNT SE DECISION MADE: 26-APR-05
BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDA B.30
BIOMERIEUX, INC. 510(k) NO: K050513(SPECIAL)
ATTN: JOCELYN JENNINGS PHONE NO : 919-620-2968
100 RODOLPHE ST SE DECISION MADE: 01-APR-05
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX90 LOW PROFILE ACETABULAR SYSTEM
BIOMET, INC. 510(k) NO: K042989(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 28-APR-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
BIONIX DEVELOPMENT CORP. 510(k) NO: K050701(TRADITIONAL)
ATTN: JAMES HUTTNER PHONE NO : 419-727-8421
5154 ENTERPRISE BLVD. SE DECISION MADE: 01-APR-05
TOLEDO, OH 43612 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALL-IN-ONE
BISCO, INC. 510(k) NO: K050647(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 20-APR-05
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIX STRETCH RESISTANT (SR) COILS
BOSTON SCIENTIFIC CORP. 510(k) NO: K050700(SPECIAL)
ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY SE DECISION MADE: 15-APR-05
FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOLIBRI SPINE
BRAINLAB AG 510(k) NO: K042721(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 19-APR-05
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEGRESS IMPLANT NEEDLE
C.R. BARD, INC. 510(k) NO: K050688(SPECIAL)
ATTN: TERRI MORRIS PHONE NO : 770-784-6774
8195 INDUSTRIAL BLVD. SE DECISION MADE: 06-APR-05
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
C.R. BARD, INC. 510(k) NO: K050724(SPECIAL)
ATTN: LORRAINE R PATA PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD. SE DECISION MADE: 18-APR-05
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRIT, MODEL HAS
CAIRE, INC. 510(k) NO: K050153(TRADITIONAL)
ATTN: DAN CHLAN PHONE NO : 770-425-4470
1800 SANDY PLAINS INDUSTRIAL SE DECISION MADE: 15-APR-05
PARKWAY, SUITE 316 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30066
DEVICE: CAMCERAM TCP
CAM IMPLANTS B.V. 510(k) NO: K050357(ABBREVIATED)
ATTN: KIM GROENEWEGAN VAN DER WEIPHONE NO : 310 715 240624
ZERNIKEDREEF 6 SE DECISION MADE: 21-APR-05
LEIDEN, NETHERLANDS 2333 CL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
CAMBRIDGE HEART, INC. 510(k) NO: K050225(SPECIAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH ST. SE DECISION MADE: 07-APR-05
SOUTHWEST RANCHES, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY MODEL CXDI-40EG
CANON, INC. 510(k) NO: K050987(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 27-APR-05
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BLOOD HAND PUMP ADMINISTRATION SET
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K050115(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 01-APR-05
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFPUMP INFILTRATION PUMP
CAROLINA MEDICAL, INC. 510(k) NO: K050324(TRADITIONAL)
ATTN: LEON WILSON PHONE NO : 336-983-5132
157 INDUSTRIAL DR. SE DECISION MADE: 27-APR-05
KING, NC 27030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEMED S200B/S200C
CERT HEALTH SCIENCES, LLC 510(k) NO: K051013(TRADITIONAL)
ATTN: TIM R EMSKY PHONE NO : 866-990-4444
10440 LITTLE PATUXENT PARKWAY SE DECISION MADE: 27-APR-05
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21044 THIRD PARTY REVIEW
DEVICE: ENDOTINE RIBBON
COAPT SYSTEMS, INC. 510(k) NO: K050611(SPECIAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7600
1820 EMBARCADERO RD. SE DECISION MADE: 06-APR-05
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7
COMPEX TECHNOLOGIES, INC. 510(k) NO: K050046(TRADITIONAL)
ATTN: BRIAN J EDWARDS PHONE NO : 651-638-0448
1811 OLD HIGHWAY 8 SE DECISION MADE: 13-APR-05
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
CONMED CORP. 510(k) NO: K050777(SPECIAL)
ATTN: MICHAEL A PATZ PHONE NO : 978-964-4253
129 CONCORD ROAD SE DECISION MADE: 22-APR-05
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821
DEVICE: COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
COOK IRELAND LTD 510(k) NO: K050578(TRADITIONAL)
ATTN: EMMETT DEVEREUX PHONE NO : 353 613 34440
O'HOLLORAN ROAD SE DECISION MADE: 22-APR-05
NATIONAL TECHNOLOGICAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: CORDIS AMIIA .014" PTA BALLOON CATHETER
CORDIS CORP. 510(k) NO: K050645(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 01-APR-05
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERTRANSIT INFUSION CATHETER
CORDIS NEUROVASCULAR, INC. 510(k) NO: K043538(TRADITIONAL)
ATTN: MARITZA CELAYA PHONE NO : 786-313-6546
14000 N.W. 57TH CT. SE DECISION MADE: 18-APR-05
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLACTIVE COLLAGEN WOUND DRESSING
COVALON TECHNOLOGIES, INC. 510(k) NO: K050177(TRADITIONAL)
ATTN: PAUL L GUILBAUD PHONE NO : 727-595-8184
14510 KANDI COURT SE DECISION MADE: 27-APR-05
LARGO, FL 33774 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANDLEX, MODEL S300X
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K050792(TRADITIONAL)
ATTN: CHANG WAN LAN PHONE NO : 886 4 23501100
NO. 17, 37TH RD. SE DECISION MADE: 21-APR-05
TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 40768
DEVICE: MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
CYDEN LIMITED 510(k) NO: K050165(TRADITIONAL)
ATTN: MICHAEL NOEL KIERNAN PHONE NO : 44 179 2485618
TECHNIUM, KINGS ROAD SE DECISION MADE: 19-APR-05
THE DOCKS 510(k) SUMMARY AVAILABLE FROM FDA
SWANSEA, WALES, UNITED KINGDOM SA1 8PH
DEVICE: FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
DAAVLIN DISTRIBUTING CO. 510(k) NO: K050695(TRADITIONAL)
ATTN: DAVID W SWANSON PHONE NO : 419-636-6304
205 WEST BEMENT ST. SE DECISION MADE: 19-APR-05
BRYAN, OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
DATEX-OHMEDA, INC. 510(k) NO: K050676(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 12-APR-05
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
DEMETECH CORP. 510(k) NO: K043539(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 06-APR-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMAS PIN
DENTAURUM, INC. 510(k) NO: K042965(TRADITIONAL)
ATTN: THOMAS LIETZ PHONE NO : 800-523-3946
10 PHEASANT RUN SE DECISION MADE: 15-APR-05
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC BRACKET ADHESIVE SYSTEM
DENTSPLY INTL. 510(k) NO: K050750(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 06-APR-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DYRACT EXTRA RESTORATIVE
DENTSPLY INTL. 510(k) NO: K050880(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 22-APR-05
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: LUPINE LOOP
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K050771(SPECIAL)
ATTN: DENISE LUCIANO PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 08-APR-05
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
DEPUY SPINE, INC. 510(k) NO: K050675(TRADITIONAL)
ATTN: LISA GILMAN PHONE NO : 508-828-8287
325 PARAMOUNT DR. SE DECISION MADE: 11-APR-05
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASORIN LIAISON EBNA IGG, LIAISON EBV IGM, LIAISON VCA IGG, LIA
DIASORIN, INC. 510(k) NO: K040120(TRADITIONAL)
ATTN: DAVID M IKEDA PHONE NO : 651-351-5592
1951 NORTHWESTERN AVE. SE DECISION MADE: 29-APR-05
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: MICROFLO-SAFE SCALP VEIN SET
DKS LOVERSAN INDUSTRIA BIOMEDICA S510(k) NO: K043328(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 15-APR-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K050974(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 29-APR-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS ULTRASOUND INFUSION SYSTEM
EKOS CORP. 510(k) NO: K041826(TRADITIONAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108
22030 20TH AVENUE S.E. SE DECISION MADE: 27-APR-05
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98021
DEVICE: SURGITRON RADIOLASE II
ELLMAN INT'L INC. 510(k) NO: K042710(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-652-1000
3333 ROYAL AVENUE SE DECISION MADE: 07-APR-05
OCEANSIDE, NY 11572-3625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT MEDICAL PEN NEEDLE
EMERGO GROUP, INC. 510(k) NO: K042917(TRADITIONAL)
ATTN: RENE VAN DE ZANDE PHONE NO : 727-797-4727
2519 MCMULLEN BOOTH RD. SE DECISION MADE: 22-APR-05
SUITE 510-295 510(k) STATEMENT
CLEARWATER, FL 33761 THIRD PARTY REVIEW
DEVICE: EPIGUARD
EPISAFE MEDICAL DEVICES, LTD. 510(k) NO: K050188(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 27-APR-05
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K043245(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 29-APR-05
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE GPS SELF-EXPANDING NITINOL STENT
EV3 CORPORATION 510(k) NO: K050725(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 20-APR-05
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEVA SINUS BALLOON DILATION CATHETER
EXPLORAMED NC1, INC. 510(k) NO: K043527(TRADITIONAL)
ATTN: WILLIAM M FACTEAU PHONE NO : 650-472-0300
2570 WEST EL CAMINO REAL SE DECISION MADE: 05-APR-05
SUITE 310 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94040
DEVICE: ICC INSULIN SAFEPRO SAFETY SYRINGE
FORMOSA MEDICAL DEVICES, INC. 510(k) NO: K050134(ABBREVIATED)
ATTN: C. Y. LIN PHONE NO :
16F,NO.182,SECT.2 SE DECISION MADE: 05-APR-05
TUNHUA S. ROAD 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 106
DEVICE: REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, RE
GE HEALTHCARE 510(k) NO: K050837(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 27-APR-05
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K050614(TRADITIONAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699
8200 WEST TOWER AVE. SE DECISION MADE: 05-APR-05
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING S
GENERAL ELECTRIC CO. 510(k) NO: K050704(SPECIAL)
ATTN: JOHN L SCHMIDT PHONE NO : 262-548-4964
P.O. BOX 414 SE DECISION MADE: 08-APR-05
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSOM HCG COMBO TEST
GENZYME DIAGNOSTICS 510(k) NO: K043385(TRADITIONAL)
ATTN: E.V. GOORCHENKO PHONE NO : 858-777-2614
6659 TOP GUN ST. SE DECISION MADE: 12-APR-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOR-TEST PA BIOLOGICAL INDICATOR KIT
GETINGE USA, INC 510(k) NO: K050664(SPECIAL)
ATTN: BARD SMITH PHONE NO : 585-214-6005
1777 EAST HENRIETTA RD. SE DECISION MADE: 07-APR-05
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-
GOOD BIOTECH CORP. 510(k) NO: K050576(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 423 596873
38, 34TH RD. SE DECISION MADE: 21-APR-05
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG CITY, CHINA (TAIWAN) 407
DEVICE: VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K042927(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
PO BOX 103 SE DECISION MADE: 15-APR-05
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BVBLUE
GRYPHUS DIAGNOSTICS, LLC 510(k) NO: K050755(SPECIAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 06-APR-05
ROCKVILLE, MD 20855 510(k) STATEMENT
DEVICE: ONE STEP HCG URINE PREGNANCY TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K043443(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 215-369-3785
8903 SPRUCE MILL DRIVE SE DECISION MADE: 08-APR-05
YARDLEY, PA 19067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUMULASE
HALOZYME THERAPEUTICS INC. 510(k) NO: K042495(TRADITIONAL)
ATTN: DON KENNARD PHONE NO : 858-794-8889
11588 SORRENTO VALLEY RD. #17 SE DECISION MADE: 14-APR-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
HAMILTON THORNE BIOSCIENCES 510(k) NO: K050768(SPECIAL)
ATTN: DIARMAID H DOUGLAS-HAMILTON PHONE NO : 978-921-2050
181 ELLIOTT ST. SE DECISION MADE: 28-APR-05
100 CUMMINGS CENTER-SUITE 465E 510(k) STATEMENT
BEVERLY, MA 01915-6101
DEVICE: DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
HAND INNOVATIONS, INC. 510(k) NO: K050932(SPECIAL)
ATTN: ERNIE HERNANDEZ PHONE NO : 305-270-6899
8905 SW 87TH AVENUE SE DECISION MADE: 26-APR-05
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33176
DEVICE: HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
HAYWOOD VOCATIONAL OPPORTUNITIES 510(k) NO: K050508(TRADITIONAL)
ATTN: TIM KELLEY PHONE NO : 828-456-4455
56 SCATES ST. SE DECISION MADE: 27-APR-05
WAYNESVILLE, NC 28786 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HL 200 ELECTRONIC STETHOSCOPE
HEALTH & LIFE CO., LTD. 510(k) NO: K050169(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 05-APR-05
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL
HEALTH & LIFE CO., LTD. 510(k) NO: K050587(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 05-APR-05
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
HEALTH & LIFE CO., LTD. 510(k) NO: K050711(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 07-APR-05
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL
HEALTH & LIFE CO., LTD. 510(k) NO: K050714(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 07-APR-05
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: HEALTH BUDDY APPLIANCE
HEALTH HERO NETWORK, INC. 510(k) NO: K050567(SPECIAL)
ATTN: GEOFFREY CLAPP PHONE NO : 650-559-1188
2570 WEST EL CAMINO REAL SE DECISION MADE: 05-APR-05
SUITE 111 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94040-1309
DEVICE: ALTAIRE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K050602(SPECIAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 07-APR-05
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVADRI BLADDER CONTROL SYSTEMS
HOLLISTER, INC. 510(k) NO: K050483(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 12-APR-05
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA DX 120: OPTION SPS EVOLUTION
HORIBA ABX 510(k) NO: K050719(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 26-APR-05
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, FRANCE 34184
DEVICE: DIODENT II DENTAL LASER SYSTEM
HOYA PHOTONICS, INC. 510(k) NO: K050274(TRADITIONAL)
ATTN: JIM GREEN PHONE NO : 510-445-4528
47733 FREMONT BLVD. SE DECISION MADE: 29-APR-05
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD-PRESSURE METER, BPW120
IDT TECHNOLOGY LIMITED 510(k) NO: K050083(TRADITIONAL)
ATTN: LEON LEONG PHONE NO : 852 276 47873
BLOCK C, 9/F., KAISER ESTATE, SE DECISION MADE: 08-APR-05
PHASE 1, 41 MAN YUE STREET 510(k) STATEMENT
HUNGHOM, HONG KONG
DEVICE: NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K050772(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD. SE DECISION MADE: 21-APR-05
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: DEPOTONE
IMPRINT PHARMACEUTICALS LIMITED 510(k) NO: K050505(TRADITIONAL)
ATTN: MERVYN LITTLE PHONE NO : +44 208 2249958
53 LANGTON ROAD SE DECISION MADE: 05-APR-05
EAST MOLESEY, SURREY, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HOME-AWAY SYSTEM, MODEL 1041
IN-X CORPORATION 510(k) NO: K042944(TRADITIONAL)
ATTN: DOUGLAS POWELL PHONE NO : 303-574-3115
6753 EAST 47TH AVE. SE DECISION MADE: 15-APR-05
UNIT D 510(k) SUMMARY AVAILABLE FROM FDA
DENVER, CO 80216
DEVICE: FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD C
INNOSPINE, INC. 510(k) NO: K043500(TRADITIONAL)
ATTN: LARAINE PANGELINA PHONE NO : 650-947-8187
11240 MAGDALENA ROAD SE DECISION MADE: 15-APR-05
LOS ALTOS HILLS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
INNOVATIVE SPINAL DESIGN, LLC 510(k) NO: K050588(TRADITIONAL)
ATTN: LEIGH COWDEN PHONE NO : 561-741-1108
1555 JUPITER PARK DR., #4 SE DECISION MADE: 21-APR-05
JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL D-DIMER HS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K050544(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 26-APR-05
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REM440
INTERACOUSTICS A/S, ASSENS 510(k) NO: K050496(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-903-4157
9675 WEST 76TH ST. SE DECISION MADE: 29-APR-05
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
INTUITIVE SURGICAL, INC. 510(k) NO: K050369(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 29-APR-05
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTR
INTUITIVE SURGICAL, INC. 510(k) NO: K050404(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2145
950 KIFER RD. SE DECISION MADE: 21-APR-05
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCULIGHT GL/GLX
IRIDEX CORP. 510(k) NO: K050562(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 14-APR-05
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCIENCE SURGICAL VISCOINJECTOR
ISCIENCE SURGICAL CORPORATION 510(k) NO: K050716(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
2 DELPHINUS SE DECISION MADE: 21-APR-05
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
IVOCLAR VIVADENT, INC. 510(k) NO: K050453(TRADITIONAL)
ATTN: DONNA HARNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 27-APR-05
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6
K-JUMP HEALTH CO., LTD. 510(k) NO: K043531(SPECIAL)
ATTN: DANIEL TSENG PHONE NO : 886 2 22991378
NO. 56, WU KUNG 5TH RD., SE DECISION MADE: 21-APR-05
WU KU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 248
DEVICE: AIDA WITH DICOM AND HL7 INTERFACE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K043324(TRADITIONAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 04-APR-05
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO ERGOCOM/ERGOCAM
KAVO AMERICA CORPORATION 510(k) NO: K050744(TRADITIONAL)
ATTN: KANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-APR-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTDOP 45 VASCULAR DOPPLER
KOVEN TECHNOLOGY, INC. 510(k) NO: K050601(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 15-APR-05
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX ANTERIOR CERVICAL PLATE SYSTEM
LANX, LLC 510(k) NO: K050774(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 11-APR-05
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
LERADO OVERSEA LTD. TWN BRANCH (BV510(k) NO: K050707(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 18-APR-05
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000
LERADO OVERSEA LTD. TWN BRANCH (BV510(k) NO: K050708(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 26-APR-05
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS
LIFECORE BIOMEDICAL, INC. 510(k) NO: K050506(ABBREVIATED)
ATTN: RACHEL KENNEDY PHONE NO : 952-368-6294
3515 LYMAN BLVD. SE DECISION MADE: 15-APR-05
CHASKA, MN 55318-3015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
LOUIS M. GERSON CO., INC. 510(k) NO: K050193(TRADITIONAL)
ATTN: ROBERT BRUNELL PHONE NO : 508-923-2145
15 SPROAT ST. SE DECISION MADE: 11-APR-05
MIDDLEBORO, MA 02346 510(k) STATEMENT
DEVICE: INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
M.K. MEDITECH CO. LTD. 510(k) NO: K050131(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 05-APR-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA-SP CO2 LASER SYSTEM
MAX ENGINEERING LTD. 510(k) NO: K050254(TRADITIONAL)
ATTN: MAUREEN O'CONNEL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 15-APR-05
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
MCKINLEY MEDICAL LLC 510(k) NO: K050770(TRADITIONAL)
ATTN: RALPH D COOEY PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 14-APR-05
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDELA SINGLE USE SILC CUP, MODEL 077.0791
MEDELA AG 510(k) NO: K041579(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 4B SE DECISION MADE: 21-APR-05
BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VACULINK, MODEL VCL 3000
MEDEVCO, INC. 510(k) NO: K043614(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT RD. SE DECISION MADE: 14-APR-05
#200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: P&P SAFETY SYRINGE
MEDEXEL MEDICAL MFG. CO., LTD. 510(k) NO: K043419(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 15-APR-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STER
MEDICAL ACTION INDUSTRIES, INC. 510(k) NO: K042526(TRADITIONAL)
ATTN: ROBIN BLANKENBAKER PHONE NO : 828-681-8820
25 HEYWOOD RD. SE DECISION MADE: 25-APR-05
ARDEN, NC 28704 510(k) STATEMENT
DEVICE: PROWIN
MEDICAL TECHNOLOGIES INTERNATIONAL510(k) NO: K050376(TRADITIONAL)
ATTN: MARC BOZENAN PHONE NO : 213-337-6700
BILTMORE TOWER SE DECISION MADE: 07-APR-05
500 SOUTH GRAND AVENUE 510(k) SUMMARY AVAILABLE FROM FDA
LOS ANGELES, CA 90071
DEVICE: OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
MEDICREA 510(k) NO: K050490(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 11-APR-05
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL G
MEDIGLOVES LTD. 510(k) NO: K050181(ABBREVIATED)
ATTN: KATHE BRENNER DEANE PHONE NO : 310-278-1930
9665 WILSHIRE BLVD. SE DECISION MADE: 13-APR-05
SUITE M-10 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY HILLS, CA 90212
DEVICE: QBRAIN
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K050703(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 317 152 23244
SCHUTTERSVELD 9 SE DECISION MADE: 21-APR-05
LEIDEN, NETHERLANDS 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANT STENT GRAFT BALLOON CATHETER
MEDTRONIC ENDOVASCULAR INNOVATIONS510(k) NO: K050038(TRADITIONAL)
ATTN: WILLIE MITCHELL PHONE NO : 707-591-2091
3576 UNOCAL PLACE SE DECISION MADE: 13-APR-05
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043053(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 11-APR-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROCHAIR
MEYRA, INC. 510(k) NO: K050560(TRADITIONAL)
ATTN: KIRK L MACKENZIE PHONE NO : 704-882-0668
12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 21-APR-05
MATTHEWS, NC 28106 510(k) STATEMENT
DEVICE: NEXUS DETACHABLE COIL SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K050543(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 27-APR-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMEDICS SPHENOID SINUS STENT
MICROMEDICS, INC. 510(k) NO: K050340(TRADITIONAL)
ATTN: THOMAS A LOPAC PHONE NO : 651-452-1977
1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 27-APR-05
SUITE 120 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: MICROWARE 200
MICROWARE INC 510(k) NO: K050740(TRADITIONAL)
ATTN: MICHAEL B MCGRAW PHONE NO : 360-896-2503
2314 SE PARK CREST AVE SE DECISION MADE: 06-APR-05
WANCOUVER, WA 98683 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROOF POSITIVE ELECTRONIC PREGNANCY TEST
MIZUHO USA, INC. 510(k) NO: K043231(TRADITIONAL)
ATTN: BENEDICT ZIN PHONE NO : 858-679-0555
12131 COMMUNITY RD. SE DECISION MADE: 25-APR-05
POWAY, CA 92064 510(k) STATEMENT
DEVICE: MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION
MONEBO TECHNOLOGIES, INC. 510(k) NO: K043380(TRADITIONAL)
ATTN: DALE J MISCZYNSKI PHONE NO : 512-732-0235
1800 BARTON CREEK BLVD SE DECISION MADE: 26-APR-05
AUSTIN, TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NVA-127-8-A NEUROVASCULAR ARRAY COIL
MRI DEVICES CORPORATION 510(k) NO: K050621(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
N27W23676 PAUL RD SE DECISION MADE: 07-APR-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL
MRI DEVICES CORPORATION 510(k) NO: K050622(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
N27W23676 PAUL RD SE DECISION MADE: 08-APR-05
PEWAUKEE, WI 53072 510(k) STATEMENT
DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K040501(TRADITIONAL)
ATTN: KAREN HARDWICK PHONE NO : 732-661-2354
125 MAY STREET SE DECISION MADE: 29-APR-05
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
N.S. UNI-GLOVES SDN. BHD. 510(k) NO: K050765(TRADITIONAL)
ATTN: KENNETH J STANTON PHONE NO : 310-328-7981
2420 CARSON ST. SUITE 125 SE DECISION MADE: 08-APR-05
TORRANCE, LA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-CARIE, MODEL N121-M1
NEKS TECHNOLOGIES, INC. 510(k) NO: K043156(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-598-8666
208 BARRINGTON OVERLOOK DRIVE SE DECISION MADE: 28-APR-05
DURHAM, NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NBD HEAD SCREW
NEW BUSINESS DEVELOPMENT, LLC 510(k) NO: K050377(TRADITIONAL)
ATTN: TIM B LUSBY PHONE NO : 678-852-5504
605 INDUSTRIAL COURT SE DECISION MADE: 07-APR-05
WOODSTOCK, GA 30189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRODE JUNCTION BOX, MODEL JE-921A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K050833(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 29-APR-05
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GROOVY IMPLANTS
NOBEL BIOCARE AB 510(k) NO: K050258(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PKWY. SE DECISION MADE: 19-APR-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYGOMA TIUNITE
NOBEL BIOCARE USA LLC 510(k) NO: K050641(SPECIAL)
ATTN: ELIZABETH MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 07-APR-05
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PRE
NOTAL VISION, INC. 510(k) NO: K050350(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE RD., STE 30 SE DECISION MADE: 29-APR-05
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE NATURAL RUBBER LATEX CONDOM
NRS GLOBAL PARTNERS 510(k) NO: K050244(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK ROAD SE DECISION MADE: 08-APR-05
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
OMRON HEALTHCARE, INC. 510(k) NO: K042505(TRADITIONAL)
ATTN: IWAO KOJIMA PHONE NO : 847-680-6200
300 LAKEVIEW PKWY. SE DECISION MADE: 05-APR-05
VERNON HILLS, IL 60061 510(k) STATEMENT
DEVICE: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
OMRON HEALTHCARE, INC. 510(k) NO: K042506(TRADITIONAL)
ATTN: IWAO KOJIMA PHONE NO : 847-680-6200
300 LAKEVIEW PKWY. SE DECISION MADE: 05-APR-05
VERNON HILLS, IL 60061 510(k) STATEMENT
DEVICE: ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINE
ORTHO DEVELOPMENT CORP. 510(k) NO: K042565(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 11-APR-05
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: CENTRION 500 C-ARM SYSTEM
OSTEOSYS CO., LTD. 510(k) NO: K050866(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 27-APR-05
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
PENTAFERTE S.P.A 510(k) NO: K041495(ABBREVIATED)
ATTN: VITTORIO SERVIDORI PHONE NO : 011 390 532778811
LOC. NOCELLA STATALE 262 SE DECISION MADE: 15-APR-05
CAMPLI (TERAMO), ITALY 64012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
PHILIPS MEDICAL SYSTEMS 510(k) NO: K050742(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 05-APR-05
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLXIS
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K050692(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 08-APR-05
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP5
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K050762(SPECIAL)
ATTN: EGON PFEIL PHONE NO : 49 703 14631926
HEWLETT-PACKARD STR.2 SE DECISION MADE: 22-APR-05
BOEBLINGEN, BADEN-WTTBG, GERMANY D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
POSSIS MEDICAL, INC. 510(k) NO: K050794(SPECIAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 28-APR-05
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
PROSURG, INC. 510(k) NO: K050488(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 01-APR-05
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: R. POON MEDICAL PRODUCTS WHEELCHAIRS
R. POON MEDICAL PRODUCTS CO., LTD.510(k) NO: K050691(TRADITIONAL)
ATTN: RICHARD GRAVER PHONE NO : 631-582-7320
10 NEWTON PLACE SE DECISION MADE: 21-APR-05
HAUPPAUGE, NY 11788 510(k) STATEMENT
DEVICE: SAFEPICO
RADIOMETER MEDICAL APS 510(k) NO: K043143(TRADITIONAL)
ATTN: LENE MEINECHE MARNAES PHONE NO : 45 382 73827
AKANDEVEJ 21 SE DECISION MADE: 22-APR-05
BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
REGENT MEDICAL AMERICAS, LLC 510(k) NO: K050533(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900
3585 ENGINEERING DR, STE 250 SE DECISION MADE: 26-APR-05
NORCROSS, GA 30092 510(k) STATEMENT
DEVICE: PLIX
RESPIRONICS, INC. 510(k) NO: K050414(TRADITIONAL)
ATTN: ZITA YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 11-APR-05
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
ROCHE DIAGNOSTICS 510(k) NO: K050423(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE ROAD PO BOX 50457 SE DECISION MADE: 22-APR-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK AVIVA SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043474(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 27-APR-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043529(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 08-APR-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
ROCHE DIAGNOSTICS CORP. 510(k) NO: K050387(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 25-APR-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURPASSON P5 NEWTRON
SATELEC 510(k) NO: K050895(TRADITIONAL)
ATTN: PASCAL DUPEYRON PHONE NO : 33 556 340607
17 AVENUE GUSTAVE EIFFEL SE DECISION MADE: 20-APR-05
Z.I. DU PHARE BP 216 510(k) SUMMARY AVAILABLE FROM FDA
MERIGNAC, GIRONDE, FRANCE 33708 THIRD PARTY REVIEW
DEVICE: TELEREHAD 2004
SCOTTCARE 510(k) NO: K050778(TRADITIONAL)
ATTN: WAYNE STRIPE PHONE NO : 800-243-9412
4791 WEST 150TH ST. SE DECISION MADE: 13-APR-05
CLEVELAND, OH 44135 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DOLPHIN INFLATION DEVICE
SEDAT S.A. 510(k) NO: K042449(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-229-9924
45900 PARSIPPANY COURT SE DECISION MADE: 18-APR-05
TEMECULA, CA 92592 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QMS VANCOMYCIN
SERADYN INC. 510(k) NO: K050419(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
7998 GEORGETOWN RD. SE DECISION MADE: 01-APR-05
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K050510(TRADITIONAL)
ATTN: RANDAL WALKER PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 01-APR-05
TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERMAGE
SHOFU DENTAL CORP. 510(k) NO: K050401(TRADITIONAL)
ATTN: DAVID MORAIS PHONE NO : 760-346-3277
1225 STONE DR. SE DECISION MADE: 28-APR-05
SAN MARCOS, CA 92069-4059 510(k) STATEMENT
DEVICE: SIC PRO
SIC INVENT AG 510(k) NO: K040757(TRADITIONAL)
ATTN: GEORG SCHILLI PHONE NO : 41 061 2613966
CH-4055 SE DECISION MADE: 13-APR-05
BASEL, SWITZERLAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO BODY PERFUSION-CT
SIEMENS AG 510(k) NO: K050867(TRADITIONAL)
ATTN: RUEDIGER KOERNER PHONE NO : +49 919 1189355
SIEMENS STRASSE 1 SE DECISION MADE: 14-APR-05
FORCHHEIM, GERMANY D-91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI
SIMPLY CLEAN AIR & WATER, INC. 510(k) NO: K042018(TRADITIONAL)
ATTN: RAYMOND KOWALEC PHONE NO : 860-231-0687
28 SHEPARD DRIVE SE DECISION MADE: 15-APR-05
NEWINGTON, CT 06131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI HAND FIXATION SYSTEM (TM)
SMALL BONE INNOVATIONS LLC 510(k) NO: K050462(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 212-583-0250
505 PARK AVENUE, 14TH FLOOR SE DECISION MADE: 26-APR-05
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES
SMART GLOVE CORP. SDN BHD 510(k) NO: K050122(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 18-APR-05
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH C
SMART GLOVE CORP. SDN BHD 510(k) NO: K050598(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 07-APR-05
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K050580(TRADITIONAL)
ATTN: KATHLEEN BURNS PHONE NO : 978-474-6301
150 MINUTEMAN ROAD SE DECISION MADE: 20-APR-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTICOAT MOISTURE CONTROL DRESSING
SMITH & NEPHEW, INC. 510(k) NO: K050030(TRADITIONAL)
ATTN: TERRY C MCMAHON PHONE NO : 727-399-3785
11775 STARKEY RD. SE DECISION MADE: 21-APR-05
LARGO, FL 33773-4727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYPAC
SMITHS MEDICAL INTERNATIONAL LTD.,510(k) NO: K043495(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON DRIVE SE DECISION MADE: 22-APR-05
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LA
SPI GLOVES SDN. BHD. 510(k) NO: K050532(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200
5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 14-APR-05
GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
IPOH 30450, MALAYSIA
DEVICE: HARMONY PORT SYSTEM, MODEL 1907 SERIES
SPINAL CONCEPTS, INC. 510(k) NO: K050706(TRADITIONAL)
ATTN: NOAH BARTSCH PHONE NO : 512-533-1840
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 15-APR-05
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING
SSL AMERICAS, INC. 510(k) NO: K042470(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2157
3585 ENGINEERING DR. SE DECISION MADE: 05-APR-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: DUREX PLAY TINGLING LUBRICANT
SSL AMERICAS, INC. 510(k) NO: K042958(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2157
3585 ENGINEERING DR. SE DECISION MADE: 08-APR-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: COMPEL SURGICAL GOWNS
STANDARD TEXTILE CO., INC. 510(k) NO: K041539(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255
ONE KNOLLCREST DR. SE DECISION MADE: 28-APR-05
P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45237-1600
DEVICE: STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-23
STELLARTECH RESEARCH CORP. 510(k) NO: K050831(SPECIAL)
ATTN: JAMES SANTOS PHONE NO : 408-331-3145
1346 BORDEAUX DR. SE DECISION MADE: 12-APR-05
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE BLOCK FIXATION SET
STRAUMANN USA, INC. 510(k) NO: K050515(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
1601 TRAPELO RD. SE DECISION MADE: 05-APR-05
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-
STRYKER INSTRUMENTS 510(k) NO: K050615(SPECIAL)
ATTN: BECKY DITTY PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 21-APR-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PATIENT SPECIFIC POLYMER IMPLANT
STRYKER LEIBINGER 510(k) NO: K043250(TRADITIONAL)
ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226
4100 EAST MILHAM AVE. SE DECISION MADE: 15-APR-05
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE AVS PL PEEK SPACER
STRYKER SPINE 510(k) NO: K050624(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 11-APR-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL DESIGN CIRCUMCISION CLAMP
SURGICAL DESIGN, INC. 510(k) NO: K043533(TRADITIONAL)
ATTN: MOHAMMAD BASHIR PHONE NO : 703-541-0196
7351-D LOCKPORT PL. SE DECISION MADE: 01-APR-05
LORTON, VA 22079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
SURGICAL SPECIALTIES CORP. 510(k) NO: K050548(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 01-APR-05
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
SURGRX, INC. 510(k) NO: K050671(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-739-0920
380 PORTAGE AVE. SE DECISION MADE: 01-APR-05
PALO ALTO, CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
SUTURES INDIA PRIVATE LIMITED 510(k) NO: K041515(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 918 028 395150
118, 3RD PHASE SE DECISION MADE: 08-APR-05
PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
BANGALORE, INDIA 560-058
DEVICE: VARELISA RECOMBI ANA PROFILE, MODEL 18496
SWEDEN DIAGNOSTICS (GERMANY) GMBH 510(k) NO: K050625(TRADITIONAL)
ATTN: SABINE KLUGBAUER PHONE NO : +49 761 47805-419
MUNZINGER STRASSE 7 SE DECISION MADE: 26-APR-05
FREIBURG, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERR VPS IMPRESSION MATERIAL
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K050604(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVENUE SE DECISION MADE: 15-APR-05
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA DS, DS APPLICATOR
SYNERON MEDICAL LTD. 510(k) NO: K050796(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 547 404616
P.O. BOX 550 SE DECISION MADE: 12-APR-05
INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM ILLIT, ISRAEL 20692
DEVICE: SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
SYNTHES (USA) 510(k) NO: K043555(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
P.O. BOX 1766 SE DECISION MADE: 12-APR-05
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
SYNTHES (USA) 510(k) NO: K050606(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 06-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
SYNTHES (USA) 510(k) NO: K050607(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 11-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
SYNTHES (USA) 510(k) NO: K050631(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868
1302 WRIGHTS LANE EAST SE DECISION MADE: 11-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
SYNTHES (USA) 510(k) NO: K050636(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-5868
1302 WRIGHTS LANE EAST SE DECISION MADE: 21-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
SYNTHES (USA) 510(k) NO: K050646(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 26-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 3.5MM CONICAL SCREWS
SYNTHES (USA) 510(k) NO: K050683(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860
1302 WRIGHTS LANE EAST SE DECISION MADE: 27-APR-05
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JSZ-MULTIPURPOSE SOLUTION
SZABOCSIK AND ASSOCIATES 510(k) NO: K050517(TRADITIONAL)
ATTN: JOHN MSZABOCSIK PHONE NO : 312-553-0828
203 N.WABASH, SUITE 1200 SE DECISION MADE: 13-APR-05
CHICAGO, IL 60601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITI-S STENT & INTRODUCER, MODEL EOXXXX
TAEWOONG MEDICAL CO., LTD 510(k) NO: K041648(TRADITIONAL)
ATTN: JAMES HARVY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 28-APR-05
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSPACH COUPLER
THE ANSPACH EFFORT, INC. 510(k) NO: K050628(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 07-APR-05
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED HARMONIC SCALPELS
THERALASE INC. 510(k) NO: K050343(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO :
600 ALDEN ROAD SE DECISION MADE: 12-APR-05
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
MARKHAM, ONTARIO, CANADA L3R 0E7
DEVICE: DATAPRO CLINICAL CHELISTRY ANALYZER
THERMO ELECTRON CORPORATION 510(k) NO: K042767(TRADITIONAL)
ATTN: BOLA NICHOLSON PHONE NO : 303-581-6425
331 SOUTH 104TH STREET SE DECISION MADE: 27-APR-05
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM
TOTOKU ELECTRIC CO., LTD 510(k) NO: K050485(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45484
300 OYA SE DECISION MADE: 07-APR-05
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & D
TOTOKU ELECTRIC CO., LTD 510(k) NO: K050616(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 21-APR-05
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I
TOTOKU ELECTRIC CO., LTD 510(k) NO: K050617(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 22-APR-05
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & D
TOTOKU ELECTRIC CO., LTD 510(k) NO: K050619(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 26-APR-05
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAXYLOC-1 SYSTEM
TRAXYZ MEDICAL, INC. 510(k) NO: K050663(TRADITIONAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 617-899-3449
290 TURNPIKE RD SUITE 6 #323 SE DECISION MADE: 08-APR-05
WESTBORO, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP RAPID DRUG SCREENING TESTS
UCP BIOSCIENCES, INC. 510(k) NO: K050540(TRADITIONAL)
ATTN: NANCY CHEN PHONE NO : 408-392-0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 29-APR-05
SAN JOSE, CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XACT.CARDIAC & XPRESS.CARDIAC
ULTRASPECT LTD. 510(k) NO: K050815(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 485 46611
BULLDING 30 MATAM SE DECISION MADE: 26-APR-05
HAFIA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAFLEX 2 (TEFILCON) CONTACT LENS
UNILENS CORP., USA 510(k) NO: K050743(SPECIAL)
ATTN: JOSEPHA BRUNO PHONE NO : 727-544-2531
10431 72ND ST. NORTH SE DECISION MADE: 13-APR-05
LARGO, FL 33777 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K043253(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 08-APR-05
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCARD 9
VARIAN INC 510(k) NO: K050321(TRADITIONAL)
ATTN: LORNA GAMBOA PHONE NO : 949-639-5415
25200 COMMERCENTRE DR. SE DECISION MADE: 18-APR-05
LAKE FOREST, CA 92630-8810 510(k) STATEMENT
DEVICE: THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K050511(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217
6464 SYCAMORE COURT NORTH SE DECISION MADE: 14-APR-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEINNOVATIONS INFILTRATION SYSTEM
VEINNOVATIONS, LLC 510(k) NO: K050474(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 14-APR-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-SCIENCES ENT-3000 SCOPE
VISION-SCIENCES, INC. 510(k) NO: K050972(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 29-APR-05
AYER, MA 01432 510(k) STATEMENT
DEVICE: VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV S
VISX, INCORPORATED 510(k) NO: K043503(TRADITIONAL)
ATTN: ALAN F RUSSELL PHONE NO : 408-773-7336
3400 CENTRAL EXPRESSWAY SE DECISION MADE: 05-APR-05
SANTA CLARA, CA 95051-0703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
VIVOMETRICS, INC. 510(k) NO: K043604(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. NW SE DECISION MADE: 29-APR-05
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODUL
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043083(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 18-APR-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE SNAP-OFF SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K050819(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 11-APR-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MOD
XTREMI-T, LLC 510(k) NO: K043339(TRADITIONAL)
ATTN: SHAWN T HUXEL PHONE NO : 609-896-0008
3131 PRINCETON PIKE, BLDG. 5 SE DECISION MADE: 18-APR-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCEVILLE, NJ 08648
DEVICE: URISCAN OPTIMA II URINE ANALYZER
YD DIAGNOSTICS 510(k) NO: K050801(SPECIAL)
ATTN: JERRI HOI PHONE NO : 818-790-9333
707 FOOTHILL BLVD. STE. 200 SE DECISION MADE: 20-APR-05
LA CANADA, CA 91011 510(k) STATEMENT
DEVICE: QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION -
Z-MEDICA CORPORATION 510(k) NO: K050769(SPECIAL)
ATTN: ROBERT V PACKARD PHONE NO : 203-294-0000
4 FAIRFIELD BLVD. SE DECISION MADE: 14-APR-05
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K042092(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 12-APR-05
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K042118(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 29-APR-05
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
ZIBO BLUE INTCO PLASTIC & RUBBER P510(k) NO: K050450(TRADITIONAL)
ATTN: KAREN ABELL PHONE NO : 909-548-4828
12390 EAST END AVENUE SE DECISION MADE: 04-APR-05
CHINO, CA 91710 510(k) STATEMENT
DEVICE: WAGNER SL REVISION STEM LATERAL
ZIMMER AUSTIN, INC. 510(k) NO: K043356(SPECIAL)
ATTN: AUDREY SWEARINGTON PHONE NO : 512-432-9255
9900 SPECTRUM DR. SE DECISION MADE: 18-APR-05
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
ZIMMER ORTHOPAEDIC SURGICAL PRODUC510(k) NO: K050433(TRADITIONAL)
ATTN: CINDY J DICKEY PHONE NO : 330-364-9493
200 WEST OHIO AVENUE SE DECISION MADE: 13-APR-05
P.O. BOX 10 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, OH 44622
DEVICE: THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-
ZIMMER TRABECULAR 510(k) NO: K050101(TRADITIONAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 15-APR-05
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
ZIMMER, INC. 510(k) NO: K050723(SPECIAL)
ATTN: TONI KINGSLEY PHONE NO : 574-372-4485
345 E. MAIN ST. SE DECISION MADE: 20-APR-05
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
ZIMMER, INC. 510(k) NO: K050761(SPECIAL)
ATTN: DARLENE BINKLEY PHONE NO : 574-372-4907
345 E. MAIN ST. SE DECISION MADE: 11-APR-05
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL E SERIES DEFIBRILLATOR
ZOLL MEDICAL CORP. 510(k) NO: K042007(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 07-APR-05
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 246
TOTAL WITH SUMMARIES 210
TOTAL WITH STATEMENTS 36
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