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510(k)s Final Decisions Rendered for January 2004 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JAN-2004 THROUGH 31-JAN-2004
DEVICE: PICCOLO MAGNESIUM TEST SYSTEM
ABAXIS, INC. 510(k) NO: K040115(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515
3240 WHIPPLE RD. SE DECISION MADE: 30-JAN-04
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION XCEED DIABETES MONITORING SYSTEM
ABBOTT LABORATORIES 510(k) NO: K033845(SPECIAL)
ATTN: TRACEY H WIELINSKI PHONE NO : 781-276-6015
4-A CROSBY DR. SE DECISION MADE: 08-JAN-04
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT DATA PORT PC, MODEL 12181
ABBOTT LABORATORIES 510(k) NO: K040114(SPECIAL)
ATTN: PATRICIA MELERSKI PHONE NO : 847-938-3718
D-389, BLDG. J-45 SE DECISION MADE: 29-JAN-04
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P
ACCESS BATTERY, INC. 510(k) NO: K032051(TRADITIONAL)
ATTN: ALEXANDER B HENDERSON PHONE NO : 800-373-3301
5357 HIGHWAY 86 SE DECISION MADE: 09-JAN-04
ELIZABETH, CO 80107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
ACUMED LLC 510(k) NO: K033639(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 15-JAN-04
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K033757(TRADITIONAL)
ATTN: KATRYNA WARREN PHONE NO : 972-309-8109
6501 WINDCREST DRIVE SUITE 100 SE DECISION MADE: 30-JAN-04
PLANO, TX 75024 510(k) STATEMENT
DEVICE: SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
AESCULAP, INC. 510(k) NO: K032108(ABBREVIATED)
ATTN: JOYCE KILROY PHONE NO : 610-984-9074
3773 CORPORATE PKWY. SE DECISION MADE: 15-JAN-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLIX LASER SYSTEMS
ALLMED SYSTEMS INC. 510(k) NO: K033423(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433
9232 KLEMETSON DRIVE SE DECISION MADE: 15-JAN-04
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHINX LASER SYSTEMS
ALLMED SYSTEMS INC. 510(k) NO: K033437(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433
9232 KLEMETSON DRIVE SE DECISION MADE: 20-JAN-04
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PRISMALIX SURGICAL LIGHT
ALM S.A. 510(k) NO: K040015(SPECIAL)
ATTN: FREDERICK R CATT PHONE NO : 585-272-5013
1777 EAST HENRIETTA ROAD SE DECISION MADE: 21-JAN-04
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ANSWER SCREW SUPPLEMENTATION SYSTEM
AMCO PRECISION TOOL 510(k) NO: K032966(TRADITIONAL)
ATTN: BARRY T BICKLEY PHONE NO : 978-681-5672
15 WOODBERRY LANE SE DECISION MADE: 13-JAN-04
NORTH ANDOVER, MA 01845 510(k) STATEMENT
DEVICE: PREMIER PLUS
AMERICAN IMEX 510(k) NO: K032003(TRADITIONAL)
ATTN: ALEX FONG PHONE NO : 949-553-8885
16520 ASTON ST. SE DECISION MADE: 07-JAN-04
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
APOGEE MEDICAL, INC. 510(k) NO: K032710(TRADITIONAL)
ATTN: DIANE N PEPER PHONE NO : 919-570-9605
90 WEATHERS ST. SE DECISION MADE: 09-JAN-04
YOUNGSVILLE, NC 27596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIOL HER-2/NEU IHC
APPLIED IMAGING CORP. 510(k) NO: K031715(TRADITIONAL)
ATTN: DIANE C OATES PHONE NO : 408-450-4304
2380 WALSH AVE., BLDG.B SE DECISION MADE: 08-JAN-04
SANTA CLARA, CA 95051 510(k) STATEMENT
DEVICE: ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHRE
ARTHREX, INC. 510(k) NO: K032245(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 14-JAN-04
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-
ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K032822(TRADITIONAL)
ATTN: MARTINA GUENDEROTH PHONE NO : 495 513 882864
KATHARINENSTR. 5 SE DECISION MADE: 08-JAN-04
LUEBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVE
ASIA PACIFIC LATEX SDN BHD 510(k) NO: K033530(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 605 291 0089
LOT 12, MEDAN TASEK, SE DECISION MADE: 28-JAN-04
TASEK INDUSTRIAL ESTATE 510(k) STATEMENT
IPOH PERAK, MALAYSIA 31400
DEVICE: ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EX
ASIA PACIFIC LATEX SDN BHD 510(k) NO: K033532(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 605 291 0089
LOT 12, MEDAN TASEK, SE DECISION MADE: 28-JAN-04
TASEK INDUSTRIAL ESTATE 510(k) STATEMENT
IPOH PERAK, MALAYSIA 31400
DEVICE: EEG MONITOR WITH BIS, MODEL A-2000
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K030267(TRADITIONAL)
ATTN: CHRISTINE VOZELLA PHONE NO : 617-559-7000
141 NEEDHAM ST. SE DECISION MADE: 15-JAN-04
NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLOTC RIA
AXIS-SHIELD BIOCHEMICALS, ASA 510(k) NO: K030655(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
P.O. BOX 262069 SE DECISION MADE: 29-JAN-04
SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZY
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K033606(TRADITIONAL)
ATTN: JUDITH FINLAYSON, PH.D. PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 30-JAN-04
LUNA PLACE 510(k) SUMMARY AVAILABLE FROM FDA
DUNDEE, SCOTLAND, UNITED KINGDOM DD2 1XA
DEVICE: CO2 CALIBRATOR/DILUENT
BAYER HEALTHCARE, DIAGNOSTICS DIVI510(k) NO: K033643(ABBREVIATED)
ATTN: KENNETH T EDDS, PH.D. PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 08-JAN-04
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD CAREFLOW CENTRAL VENOUS CATHETER
BECTON DICKINSON & CO. 510(k) NO: K033500(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE STREET SE DECISION MADE: 29-JAN-04
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG
BECTON DICKINSON & CO. 510(k) NO: K033560(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 14-JAN-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANA
BECTON, DICKINSON AND COMPANY 510(k) NO: K033557(TRADITIONAL)
ATTN: MICHELLE B BANDY PHONE NO : 410-316-4778
7 LOVETON CIR. SE DECISION MADE: 14-JAN-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOLD DENTAL CASTING ALLOYS
BEGO U.S.A. 510(k) NO: K033279(TRADITIONAL)
ATTN: WILLIAM OREMUS PHONE NO : 401-334-9261
24 ALBION RD., SUITE 103 SE DECISION MADE: 15-JAN-04
LINCOLN, RI 02865 510(k) STATEMENT
DEVICE: BIOCENTREX CARDIAC PANEL
BIOCENTREX 510(k) NO: K033155(TRADITIONAL)
ATTN: THOMAS H GROVE PHONE NO : 805-968-3099
6100 BRISTOL PARKWAY SE DECISION MADE: 12-JAN-04
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATERLASE
BIOLASE TECHNOLOGY, INC. 510(k) NO: K030523(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 30-JAN-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K033455(TRADITIONAL)
ATTN: DONNA HERATY PHONE NO : 760-727-5600
P.O. BOX 1360 SE DECISION MADE: 15-JAN-04
VISTA, CA 92085-1360 510(k) STATEMENT
DEVICE: MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
BIOSITE INCORPORATED 510(k) NO: K032235(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-597-4815
11030 ROSELLE ST. SE DECISION MADE: 28-JAN-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TESCERA U-BAR AND BARRELS
BISCO, INC. 510(k) NO: K033472(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 15-JAN-04
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISBLOCK
BISCO, INC. 510(k) NO: K033521(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 16-JAN-04
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAPEX
BISCO, INC. 510(k) NO: K033585(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 16-JAN-04
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC V-18 CONTROL WIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K033742(TRADITIONAL)
ATTN: DEBORAH THOMAS PHONE NO : 763-494-2078
ONE SCIMED PLACE SE DECISION MADE: 12-JAN-04
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
BOSTON SCIENTIFIC CORP. 510(k) NO: K034061(SPECIAL)
ATTN: CHRISTINA L ROWE PHONE NO : 408-895-3526
2710 ORCHARD PKWY. SE DECISION MADE: 30-JAN-04
SAN JOSE, CA 95134 510(k) STATEMENT
DEVICE: EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 641
BOSTON SCIENTIFIC CORP. 510(k) NO: K040018(SPECIAL)
ATTN: JAMES D MCMAHON PHONE NO : 508-652-5566
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 20-JAN-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDONIC CA620/530 HEMATOLOGY ANALYZER
BOULE MEDICAL AB 510(k) NO: K032214(TRADITIONAL)
ATTN: ANDREW SWANSON PHONE NO : 954-791-1773
1660 N.W. 65TH AVE SUITE 2 SE DECISION MADE: 29-JAN-04
PLANTATION, FL 33313 510(k) STATEMENT
DEVICE: INTUITION IMAGE
BRAINLAB, AG 510(k) NO: K032511(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 21-JAN-04
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD ELIMINATOR PET BALLOON DILATORS
C.R. BARD, INC. 510(k) NO: K033936(SPECIAL)
ATTN: MICHAEL A PATZ PHONE NO : 978-262-4868
129 CONCORD ROAD SE DECISION MADE: 14-JAN-04
BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821
DEVICE: POLY PER-Q-CATH PICC CATHETERS
C.R. BARD, INC. 510(k) NO: K034019(SPECIAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 21-JAN-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GROSHONG NXT PICC CATHETERS
C.R. BARD, INC. 510(k) NO: K034020(SPECIAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 21-JAN-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO X-PORT DUO PORT
C.R. BARD, INC. 510(k) NO: K034065(SPECIAL)
ATTN: ANGELA BRADY PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 15-JAN-04
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA CBEAM PULSE DYE LASER SYSTEM
CANDELA CORP. 510(k) NO: K033331(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 16-JAN-04
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA VBEAM PULSE DYE LASER SYSTEM
CANDELA CORP. 510(k) NO: K033461(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 16-JAN-04
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODA CX1 MOTION ANALYSIS SYSTEM
CHARNWOOD DYNAMICS LTD. 510(k) NO: K033514(TRADITIONAL)
ATTN: DAVID L MITCHELSON PHONE NO : 44 116 2301060
UNIT 2, VICTORIA MILLS SE DECISION MADE: 06-JAN-04
FOWKE ST. 510(k) SUMMARY AVAILABLE FROM FDA
ROTHLEY, LEICESTERSHIRE, UNITED KINGDOM LE7 7PJ
DEVICE: OLYMPUS URINE CALIBRATOR
CLINIQA CORPORATION 510(k) NO: K033910(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 30-JAN-04
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: GII SPINAL FIXATION SYSTEM
CO-LIGNE AG 510(k) NO: K032604(TRADITIONAL)
ATTN: ARIEL DUJOVNE, ING. M.SC. PHONE NO : 514 322 8560
9260 VIAU BLVD. SE DECISION MADE: 20-JAN-04
MONTREAL, CANADA H1R 2V8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE COAT SE BOND
COLTENE/WHALEDENT INC. 510(k) NO: K033760(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVE. SE DECISION MADE: 23-JAN-04
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: HERO 1, MODEL LY-ESB220
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K031621(TRADITIONAL)
ATTN: ERIC H.C. LEE PHONE NO : 886 5 2892093
NO. 120 NAN SHIANG TSUEN, SE DECISION MADE: 22-JAN-04
SHOEI SHANG SHIANG 510(k) SUMMARY AVAILABLE FROM FDA
CHIA-YI, CHINA (TAIWAN)
DEVICE: HUBERPRO SAFETY HUBER INFUSION SET
COMMAND MEDICAL PRODUCTS 510(k) NO: K033515(TRADITIONAL)
ATTN: JOYCE VYTLACIL PHONE NO : 386-672-8116
15 SIGNAL AVE. SE DECISION MADE: 22-JAN-04
ORMOND BEACH, FL 32174 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGAND PLUS CONTROL LEVEL 1-3
CONSOLIDATED TECHNOLOGY 510(k) NO: K033344(TRADITIONAL)
ATTN: CANDICE BETZ PHONE NO : 512-445-5100
4401 FREIDRICH LN. BLDG 1 SE DECISION MADE: 16-JAN-04
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744-1832
DEVICE: MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-I
COOK UROLOGICAL, INC. 510(k) NO: K033903(SPECIAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 16-JAN-04
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
COOK UROLOGICAL, INC. 510(k) NO: K033904(SPECIAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 16-JAN-04
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COA
COOK, INC. 510(k) NO: K033843(TRADITIONAL)
ATTN: JENNIFER BOSLEY, MBA PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 15-JAN-04
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
CORGENIX, INC. 510(k) NO: K034013(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 08-JAN-04
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: CP SLEEVE AND RIVER SLEEVE
CP MEDICAL 510(k) NO: K034062(SPECIAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 30-JAN-04
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRISTAR AESTHETIC WORKSTATION LASER
CYNOSURE, INC. 510(k) NO: K033176(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 21-JAN-04
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CAL
DADE BEHRING, INC. 510(k) NO: K033525(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 12-JAN-04
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: N HIGH SENSITIVITY CRP
DADE BEHRING, INC. 510(k) NO: K033908(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
GLASGOW SITE SE DECISION MADE: 22-JAN-04
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
DAKOCYTOMATION A/S 510(k) NO: K032692(TRADITIONAL)
ATTN: NANCY J STARK PHONE NO : 773-489-5721
2128 W EVERGREEN AVE. SE DECISION MADE: 22-JAN-04
CHICAGO, IL 60622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDEIA PCE CHLAMYDIA
DAKOCYTOMATION LTD 510(k) NO: K033865(SPECIAL)
ATTN: JENNIE OATES PHONE NO : 440 135 3669911
DENMARK HOUSE, ANGEL DROVE SE DECISION MADE: 21-JAN-04
ELY, CAMBRIDGESHIRE, UNITED KINGDO510(k) STATEMENT
DEVICE: PREPAIR
DANVILLE MATERIALS, INC. 510(k) NO: K033215(TRADITIONAL)
ATTN: CRAIG R BRUNS PHONE NO : 925-838-7940
2021 OMEGA DR. SE DECISION MADE: 09-JAN-04
SAN RAMON, CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATCH MASTER LOW FUSION PORCELAIN
DAVIS SCHOTTLANDER & DAVIS, LTD. 510(k) NO: K024252(TRADITIONAL)
ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591
54 RIVERVIEW AVE. SE DECISION MADE: 22-JAN-04
TONAWANDA, NY 14150-5260 510(k) STATEMENT
DEVICE: ENDOPURE ROOT CANAL CLEANSER
DENTSPLY INTL. 510(k) NO: K032361(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 12-JAN-04
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: CARRARA PRESS SYSTEM
DENTSPLY INTL. 510(k) NO: K033667(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVENUE SE DECISION MADE: 23-JAN-04
P.O. BOX 872 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405-0872
DEVICE: PINNACLE REVISION SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033338(SPECIAL)
ATTN: BOB FRIDDLE PHONE NO : 574-371-4925
700 ORTHOPAEDIC DR. SE DECISION MADE: 08-JAN-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K034055(SPECIAL)
ATTN: EDWARD M LEVINE, PH.D. PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 21-JAN-04
LOS ANGELES, CA 90045-5597 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
DIAMODENT 510(k) NO: K034022(TRADITIONAL)
ATTN: JEFF RASSOLI PHONE NO : 714-632-3206
2737 EAST REGAL PARK AVE. SE DECISION MADE: 30-JAN-04
ANAHEIM, CA 92806 510(k) STATEMENT
DEVICE: GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033055(TRADITIONAL)
ATTN: LINDA STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 30-JAN-04
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033056(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 30-JAN-04
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEM
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033058(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 30-JAN-04
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I
DIDECO S.P.A. 510(k) NO: K033323(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 13-JAN-04
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
DIDECO S.P.A. 510(k) NO: K033987(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 08-JAN-04
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKY BONE EXPANDER SYSTEM
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K034037(SPECIAL)
ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 28-JAN-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH
DISCUS DENTAL INC. 510(k) NO: K033381(TRADITIONAL)
ATTN: STEVEN L ZIEMBA PHONE NO : 310-845-8345
8550 HIGUERA ST. SE DECISION MADE: 27-JAN-04
CULVER CITY, CA 90232 510(k) STATEMENT
DEVICE: LUXAFORM PLUS
DMG USA, INC. 510(k) NO: K033227(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 16-JAN-04
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K033312(TRADITIONAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 13-JAN-04
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUOPATH VEROTOXINS GLISA TEST
EMD CHEMICALS INC. 510(k) NO: K031367(TRADITIONAL)
ATTN: ANNA G BENTLEY PHONE NO : 856-423-6300
480 S. DEMOCRAT RD. SE DECISION MADE: 23-JAN-04
GIBBSTOWN, NJ 08027 510(k) STATEMENT
DEVICE: ERBE HELIX HYDRO-JET
ERBE USA, INC. 510(k) NO: K033590(TRADITIONAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2225 NORTHWEST PKWY. SE DECISION MADE: 30-JAN-04
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
ESA, INC. 510(k) NO: K032199(TRADITIONAL)
ATTN: HAROLD ASP PHONE NO : 978-250-7106
22 ALPHA RD. SE DECISION MADE: 30-JAN-04
CHELMSFORD, MA 01824-4171 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
ETHICON ENDO-SURGERY, INC. 510(k) NO: K031147(TRADITIONAL)
ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123
4545 CREEK RD. SE DECISION MADE: 12-JAN-04
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
EVENT MEDICAL LTD 510(k) NO: K030341(TRADITIONAL)
ATTN: ROBBIE WALSH PHONE NO : 353 91 764472
6A LIOSBAN BUSINESS PARK SE DECISION MADE: 16-JAN-04
TUAM ROAD 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: SPACER G TEMPORARY HIP PROSTHESIS
EXACTECH, INC. 510(k) NO: K031841(TRADITIONAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 22-JAN-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORACLE ORAL MASK, MODEL HC451A
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K033087(SPECIAL)
ATTN: JAMES THOMPSON PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 14-JAN-04
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INT
FLOWMEDICA, INC. 510(k) NO: K033569(TRADITIONAL)
ATTN: JEFF ELKINS PHONE NO : 510-252-9500
46563 FREMONT BLVD SE DECISION MADE: 13-JAN-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (R
FOCUS MEDICAL, LLC. 510(k) NO: K032667(TRADITIONAL)
ATTN: JOHN B LEE PHONE NO : 203-730-8885
23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 23-JAN-04
BETHEL, CT 06801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS ULTRAFLO HPX HEMODIALYZER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K034064(SPECIAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE. SE DECISION MADE: 30-JAN-04
LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSENS
FRIENDLY SENSORS AG 510(k) NO: K033193(ABBREVIATED)
ATTN: TRISH LANDRY PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 23-JAN-04
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K033377(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-602-3774
419 WEST AVE. SE DECISION MADE: 09-JAN-04
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIODHOC
FUTURE MEDICAL SYSTEMS, SA 510(k) NO: K024185(TRADITIONAL)
ATTN: STEVE JANIN PHONE NO : 410-761-9411
504 MCCORMICK DR. SE DECISION MADE: 15-JAN-04
GLEN BURNIE, MD 21061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS VERTICAL PLATFORM LIFT
GARAVENTA ACCESSIBILITY 510(k) NO: K033469(ABBREVIATED)
ATTN: NORM COOPER PHONE NO : 604 594 0422
7505 - 134A STREET SE DECISION MADE: 07-JAN-04
SURREY, BRITISH COLUMBIA, CANADA V510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR 9500 INFORMATION MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K033964(SPECIAL)
ATTN: ANDREW KLUESSENDORF PHONE NO : 414-362-3063
8200 WEST TOWER AVE. SE DECISION MADE: 15-JAN-04
MILWAUKEE, WI 53223 510(k) STATEMENT
DEVICE: BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
GEISTLICH-PHARMA 510(k) NO: K033815(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-408-9222
1301 K STREET NW SE DECISION MADE: 15-JAN-04
SUITE 600, EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: AMERSHAM HEALTH NEEDLE-GUARD
GETTIG PHARMACEUTICAL INSTRUMENT C510(k) NO: K033409(TRADITIONAL)
ATTN: JAMES A BENZ PHONE NO : 814-422-8892
1 STREAM SIDE PL. WEST SE DECISION MADE: 21-JAN-04
PO BOX 85 510(k) SUMMARY AVAILABLE FROM FDA
SPRING MILLS, PA 16875-0085
DEVICE: VARIFLEX
GREAT LAKES ORTHODONTICS, LTD. 510(k) NO: K033632(TRADITIONAL)
ATTN: MARK LAUREN PHONE NO : 716-871-1161
200 COOPER AVE.DR. SE DECISION MADE: 21-JAN-04
TONAWANDA, NY 14150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILINK .018 BILIARY STENT SYSTEM
GUIDANT CORP. 510(k) NO: K033834(SPECIAL)
ATTN: MICHELLE GROSSMAN PHONE NO : 408-845-2213
3200 LAKESIDE DR. SE DECISION MADE: 02-JAN-04
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL BONE FIXATION SYSTEM
HAND INNOVATIONS, INC. 510(k) NO: K033406(SPECIAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
8905 SW 87TH AVE. SE DECISION MADE: 15-JAN-04
MIAMI, FL 33176-2227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO V-CATH POLY PICC
HDC CORP. 510(k) NO: K033853(SPECIAL)
ATTN: EARL SMART PHONE NO : 408-942-7340
628 GIBRALTAR CT. SE DECISION MADE: 14-JAN-04
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K033796(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 4289591
AMSTEL 320-I SE DECISION MADE: 30-JAN-04
AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIC
HERAEUS KULZER, INC. 510(k) NO: K033628(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 16-JAN-04
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO KNEE SYSTEM - TIBIAL INSERTS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K033342(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
59 ROUTE 17 SE DECISION MADE: 15-JAN-04
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K033476(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SE DECISION MADE: 20-JAN-04
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K033837(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DRIVE SE DECISION MADE: 08-JAN-04
MAHWAH, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA3 NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K034002(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 15-JAN-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
HYCOR BIOMEDICAL LTD. 510(k) NO: K033744(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111
PENTLANDS SCIENCE PARK SE DECISION MADE: 20-JAN-04
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: IBL C3D-CIC EIA TEST
IBL GMBH 510(k) NO: K032796(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 13-JAN-04
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
IDT TECHNOLOGY LIMITED 510(k) NO: K031167(TRADITIONAL)
ATTN: STEPHEN LI PHONE NO : 852 276 47873
BLOCK C, 9/F., KAISER ESTATE, SE DECISION MADE: 28-JAN-04
PHASE 1, 41 MAN YUE STREET 510(k) STATEMENT
HUNGHOM, HONG KONG, CHINA
DEVICE: 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
IMPLANT INNOVATIONS, INC. 510(k) NO: K032263(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-776-6913
4555 RIVERSIDE DR. SE DECISION MADE: 28-JAN-04
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
IMPLEX CORP. 510(k) NO: K031962(TRADITIONAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 08-JAN-04
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEXATITE QUICK ACRYLIC
IMTEC CORP. 510(k) NO: K033432(TRADITIONAL)
ATTN: BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 15-JAN-04
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD
INFUSION DYNAMICS, INC. 510(k) NO: K030739(TRADITIONAL)
ATTN: THOMAS BECZE PHONE NO : 301-228-3122
5340 SPECTRUM DRIVE, SUITE N SE DECISION MADE: 14-JAN-04
FREDERICK, MD 21703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL-AIR CRITICAL CARE
INNOMED TECHNOLOGIES 510(k) NO: K031896(TRADITIONAL)
ATTN: FRANK PELC PHONE NO : 724-838-7880
506 GARDEN STREET SE DECISION MADE: 14-JAN-04
GREENSBURG, PA 15601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K033922(SPECIAL)
ATTN: CAROLYN BITETTI PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 07-JAN-04
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: ACL TOP MODEL, TOP
INSTRUMENTATION LABORATORY CO. 510(k) NO: K033414(ABBREVIATED)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 12-JAN-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL LIQUID ANTITHROMBIN XL
INSTRUMENTATION LABORATORY CO. 510(k) NO: K033775(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 02-JAN-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K032031(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 07-JAN-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSS
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K033929(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 12-JAN-04
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: EARLY CLEAVAGE MEDIUM (ECM)
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K033462(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 15-JAN-04
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAM
IS2 RESEARCH, INC. 510(k) NO: K033956(SPECIAL)
ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755
20 GURDWARA RD., UNITS 3-10 SE DECISION MADE: 20-JAN-04
OTTAWA, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
IVOCLAR VIVADENT AG 510(k) NO: K033773(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 15-JAN-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JOSTRA SUCKERS, MODEL JS
JOSTRA AG 510(k) NO: K020983(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA RD. SE DECISION MADE: 30-JAN-04
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND SETUP 2000
K&S; ASSOC., INC. 510(k) NO: K032886(TRADITIONAL)
ATTN: VIVIAN DEAN PHONE NO : 615-883-9760
1926 ELM TREE DR. SE DECISION MADE: 09-JAN-04
NASHVILLE, TN 37210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS-MARTIN ORTHO ANCHORAGE SYSTEM
KLS-MARTIN L.P. 510(k) NO: K033483(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 15-JAN-04
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: CLEARFIL PROTECT BOND
KURARAY MEDICAL INC. 510(k) NO: K033938(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SE DECISION MADE: 29-JAN-04
11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
LUMEND, INC. 510(k) NO: K033535(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400
400 CHESAPEAKE DR. SE DECISION MADE: 07-JAN-04
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
M.K. MEDITECH CO. LTD. 510(k) NO: K034031(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 21-JAN-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-SMART, MODEL B-01
MACOSTA MEDICAL USA, LLC 510(k) NO: K031128(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 15-JAN-04
AYER, MA 01432 510(k) STATEMENT
DEVICE: MULTIPLACE HYPERBARIC SYSTEM, MODEL "MMI HYPERBARIC CHAMBER SYST
MAKAI MARINE INDUSTRIES, INC. 510(k) NO: K030418(TRADITIONAL)
ATTN: MARC R KAISER PHONE NO : 305-987-2247
P.O. BOX 272039 SE DECISION MADE: 29-JAN-04
BOCA RATON, FL 33427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
MASIMO CORP. 510(k) NO: K033349(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 28-JAN-04
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEASSIST DEVICE
MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K033413(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
BEIT HAPA'AMON BOX 124 SE DECISION MADE: 07-JAN-04
20 HATA'AS (ROOM 213) 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE
MDM ENTERPRISE CORP. 510(k) NO: K033835(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909-465-9188
SE DECISION MADE: 22-JAN-04
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-LOGICS, MODEL ML7090
MED-LOGICS, INC. 510(k) NO: K033293(TRADITIONAL)
ATTN: ROD ROSS PHONE NO : 949-582-3891
26061 MERIT CIRCLE, SUITE #102 SE DECISION MADE: 13-JAN-04
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULI
MED2000 SPA 510(k) NO: K031908(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., STE 200 SE DECISION MADE: 14-JAN-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPREHENSIVE NEUROMUSCULAR PROFILER
MEDICAL TECHNOLOGIES UNLIMITED, IN510(k) NO: K031995(TRADITIONAL)
ATTN: ANGELA MORRIS PHONE NO : 505-797-7789
7538 BEAR CANYON RD. NE SE DECISION MADE: 07-JAN-04
ALBUQUERQUE, NM 87109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
MEDIPLUS LTD. 510(k) NO: K031617(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 16-JAN-04
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
MEDISISS 510(k) NO: K030598(TRADITIONAL)
ATTN: MARY ANN BARKER PHONE NO : 541-549-4164
723 CURTIS COURT SE DECISION MADE: 23-JAN-04
PO BOX 2060 510(k) SUMMARY AVAILABLE FROM FDA
SISTERS, OR 97759
DEVICE: AEROMIST LT, MODEL HCS15004
MEDLINE INDUSTRIES, INC. 510(k) NO: K031686(TRADITIONAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PL. SE DECISION MADE: 21-JAN-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
MEDLOGIC GLOBAL LIMITED 510(k) NO: K031321(TRADITIONAL)
ATTN: MEL LONGHURST PHONE NO : 441 752 209955
WESTERN WOOD WAY SE DECISION MADE: 21-JAN-04
LANGAGE SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, DEVON, UNITED KINGDOM PL7 5BG
DEVICE: MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S5
MEDTRONIC INC. CARDIAC RHYTHM MANA510(k) NO: K033989(SPECIAL)
ATTN: KRISTY K MOLLNER PHONE NO : 763-514-4189
7000 CENTRAL AVE. N.E. SE DECISION MADE: 22-JAN-04
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH
MEDTRONIC NEUROSURGERY 510(k) NO: K033850(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR., SE DECISION MADE: 13-JAN-04
GOLETA, CA 93117 510(k) STATEMENT
DEVICE: SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
MEDTRONIC, INC. 510(k) NO: K034058(SPECIAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 29-JAN-04
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE,
MICRO THERAPEUTICS, INC. 510(k) NO: K033372(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 09-JAN-04
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K033817(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 08-JAN-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971,
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K033818(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 08-JAN-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K034023(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 15-JAN-04
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL MEDICAL DEVICE CAUTERY
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K023506(TRADITIONAL)
ATTN: ROGER STRUBE PHONE NO : 804-353-7160
1705 DABNEY RD. SE DECISION MADE: 13-JAN-04
RICHMOND, VA 23230 510(k) STATEMENT
DEVICE: CLIPLOC SOFT TISSUE MARKER 18G/100MM (4"), /130MM (5 1/8"), /150
MRI DEVICES CORP. 510(k) NO: K033447(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 28-JAN-04
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWPORT E500 WAVE VENTILATOR
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K030780(TRADITIONAL)
ATTN: RICHARD WATERS PHONE NO : 949-642-3910
760 WEST 16TH ST., BLDG. N SE DECISION MADE: 23-JAN-04
COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K033302(SPECIAL)
ATTN: JIMMY WONG PHONE NO : 949-940-7260
1311 CALLE BATIDO SE DECISION MADE: 26-JAN-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K033475(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 07-JAN-04
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDI PASSIVE SPHERES
NORTHERN DIGITAL, INC. 510(k) NO: K033621(TRADITIONAL)
ATTN: NANCY RUTH PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 27-JAN-04
DUNDAS, ONTARIO, CANADA L9H 7P3 510(k) STATEMENT
DEVICE: NOVA GLUCOSE CONTROL SOLUTIONS
NOVA BIOMEDICAL CORP. 510(k) NO: K033433(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 02-JAN-04
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
NOVOSCI CORP. 510(k) NO: K033328(TRADITIONAL)
ATTN: LEANN LATHAM PHONE NO : 281-363-4949
2828 NORTH CRESCENT RIDGE DR. SE DECISION MADE: 16-JAN-04
THE WOODLANDS, TX 77381-3902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS VIDEO URETEROSCOPE, NTSC
OLYMPUS WINTER & IBE GMBH 510(k) NO: K033651(SPECIAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
TWO CORPORATE CENTER DR. SE DECISION MADE: 30-JAN-04
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE
ONE TOUCH PRODUCTS CO., LTD. 510(k) NO: K033877(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909-465-9188
7668 BELPINE PLACE SE DECISION MADE: 16-JAN-04
RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT
DEVICE: OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-
OPTICON MEDICAL, INC. 510(k) NO: K033830(SPECIAL)
ATTN: GERARD J PRUD'HOMME, ESQ. PHONE NO : 202-637-5735
555 THIRTEENTH STREET, NW SE DECISION MADE: 09-JAN-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
ORTHOPEDIC DESIGNS, INC. (ODI) 510(k) NO: K033286(TRADITIONAL)
ATTN: JOHN SODEIKA PHONE NO : 727-570-9200
9521 INTERNATIONAL COURT NORTH SE DECISION MADE: 12-JAN-04
ST. PETERSBURG, FL 33716 510(k) STATEMENT
DEVICE: OSTEOMED ORTHODONTIC SCREW SYSTEM
OSTEOMED L.P. 510(k) NO: K031936(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 07-JAN-04
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCALETRON PIEZO ULTRASOUND SCALER
PAC-DENT INTERNATIONAL (SUZHOU), L510(k) NO: K033120(TRADITIONAL)
ATTN: DANIEL WANG PHONE NO : 909-839-0888
21078 COMMERCE POINT DR. SE DECISION MADE: 29-JAN-04
WALNUT, CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
PALL MEDICAL 510(k) NO: K033991(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 22-JAN-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRJ
PARAMED SRL 510(k) NO: K033507(TRADITIONAL)
ATTN: DIANA UPTON PHONE NO : 201-692-1945
719 CATALPA AVENUE SE DECISION MADE: 20-JAN-04
TEANECK, NJ 07666 510(k) STATEMENT
DEVICE: PERIO PROTECT TRAY
PERIO PROTECT LLC 510(k) NO: K031809(TRADITIONAL)
ATTN: DAVID L ROSEN PHONE NO : 202-238-7749
1625 MASSACHUSETTS AVENUE NW; SE DECISION MADE: 23-JAN-04
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036-2247
DEVICE: STREET
PERMOBIL A.B. 510(k) NO: K032765(TRADITIONAL)
ATTN: BENGT PERSSON PHONE NO : +46 60 595900
ARVALTSVAGEN 10 SE DECISION MADE: 30-JAN-04
BOX 120 510(k) SUMMARY AVAILABLE FROM FDA
TIMRA, SWEDEN S-861 23
DEVICE: EASI ECG ALGORITHM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K033513(TRADITIONAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 15-JAN-04
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACQSIM-MULTISLICE-CT, MODEL 453567042271
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K033357(TRADITIONAL)
ATTN: ROBERT B SMITH PHONE NO : 440-483-7474
595 MINER ROAD SE DECISION MADE: 09-JAN-04
HIGHLAND HTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K034003(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 08-JAN-04
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041 THIRD PARTY REVIEW
DEVICE: POSTERIOR CABLE SCREW
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K022908(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 22-JAN-04
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROMOS SHOULDER
PLUS ORTHOPEDICS 510(k) NO: K032126(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 08-JAN-04
ROUND ROCK, TX 78681-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
PORTEX LTD. 510(k) NO: K032112(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 440 130 3208011
MILITARY ROAD SE DECISION MADE: 26-JAN-04
HYTHE, KENT 510(k) SUMMARY AVAILABLE FROM FDA
ENGLAND CT21 6DB, UNITED KINGDOM
DEVICE: MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
PORTLAND ORTHOPAEDICS PTY. LTD. 510(k) NO: K032641(SPECIAL)
ATTN: DAVID SEKEL PHONE NO : 011 612 96668444
3/44 MCCAULEY ST. SE DECISION MADE: 20-JAN-04
MATRAVILLE NSW, AUSTRALIA 2036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVS "PIVOT" STEERABLE DELIVERY SYSTEM MICROCATHETER
PRECISION VASCULAR 510(k) NO: K033726(SPECIAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1700
2405 WEST ORTON CIRCLE SE DECISION MADE: 16-JAN-04
WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER IMPLANT CEMENT, MODEL 3001450
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K033309(TRADITIONAL)
ATTN: BARRY HALE PHONE NO : 816-322-4641
7707 E. 201 TERR SE DECISION MADE: 26-JAN-04
BELTON, MO 64012 510(k) STATEMENT
DEVICE: PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF D
PROFESSIONAL DENTAL TECHNOLOGIES T510(k) NO: K033449(TRADITIONAL)
ATTN: JOANN UNDERWOOD PHONE NO : 870-698-3478
500 WHITE DR. SE DECISION MADE: 07-JAN-04
BATESVILLE, AR 72501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIANOX DELIVERY SYSTEM, MODEL II
PULMONOX MEDICAL, INC. 510(k) NO: K033779(SPECIAL)
ATTN: PAULA TOMAT PHONE NO : 780 451 3660
10835-120 ST. SE DECISION MADE: 26-JAN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
EDMONTON, AB, CANADA T5H 3P9
DEVICE: MODIFICATION TO SERAQUEST VCA IGM
QUEST INTL., INC. 510(k) NO: K033780(SPECIAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERR. SE DECISION MADE: 15-JAN-04
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SERAQUEST EB VCA IGG
QUEST INTL., INC. 510(k) NO: K033915(SPECIAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERR. SE DECISION MADE: 16-JAN-04
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CA-1500
R2 TECHNOLOGY, INC. 510(k) NO: K040028(TRADITIONAL)
ATTN: KATHY O'SHAUGHNESSY PHONE NO : 408-481-5696
1195 WEST FREMONT AVE. SE DECISION MADE: 22-JAN-04
SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR,
RECOM MANAGED SYSTEMS, INC. 510(k) NO: K032882(ABBREVIATED)
ATTN: WILLAM R MATTHEWS PHONE NO : 818-432-4560
4705 LAUREL CANYON BLVD. SE DECISION MADE: 28-JAN-04
SUITE 203 510(k) SUMMARY AVAILABLE FROM FDA
VALLEY VILLAGE, CA 91607
DEVICE: NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
REICHERT INC. 510(k) NO: K032799(TRADITIONAL)
ATTN: FRANK DREXELIUS PHONE NO : 716-686-4548
3374 WALDEN AVE. SE DECISION MADE: 20-JAN-04
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: ESPRIT VENTILATOR, MODEL V1000
RESPIRONICS, INC. 510(k) NO: K034040(SPECIAL)
ATTN: ANIL BHALANI PHONE NO : 760-918-7300
2271 COSMOS COURT SE DECISION MADE: 21-JAN-04
CARLSBAD, CA 92009-1517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEEL SNUGGLER, MODEL 99047
RESPIRONICS, INC. 510(k) NO: K040044(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 27-JAN-04
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ROCHE ONLINE TDM QUINIDINE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032332(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 317-845-2000
9115 HAGUE RD. SE DECISION MADE: 12-JAN-04
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ROCHE ONLINE TDM LIDOCAINE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032334(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
P.O. BOX 50457 SE DECISION MADE: 12-JAN-04
9115 HAGUE RD. 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ELECSYS PRECICONTROL MULTIANALYTE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033937(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 07-JAN-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
RON-TECH MEDICAL LTD. 510(k) NO: K032585(SPECIAL)
ATTN: DORON KILCHEVSKY PHONE NO : 972 3 9235514
26 HASIVIM ST. SE DECISION MADE: 09-JAN-04
KIRYAT MATALON 510(k) SUMMARY AVAILABLE FROM FDA
PETACH-TIKVA, ISRAEL 49170
DEVICE: MEDICAL MAGGOTS
RONALD A. SHERMAN 510(k) NO: K033391(TRADITIONAL)
ATTN: RONALD A SHERMAN PHONE NO : 949-509-0989
36 UREY COURT SE DECISION MADE: 12-JAN-04
IRVINE, CA 92612 510(k) STATEMENT
DEVICE: STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
RUDOLF STORZ GMBH 510(k) NO: K033660(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 4289591
AMSTEL 320-1 SE DECISION MADE: 07-JAN-04
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: FLOSENSE II, MODEL 29-8040
SDI DIAGNOSTICS, INC. 510(k) NO: K033939(TRADITIONAL)
ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033
10 HAMPDEN DR. SE DECISION MADE: 30-JAN-04
EASTON, MA 02375 510(k) STATEMENT
DEVICE: SEA-BAND
SEA-BAND UK LTD. 510(k) NO: K033268(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 44 1763222505
BUSINESS & TECH. CENTER SE DECISION MADE: 07-JAN-04
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, HERTS., UNITED KINGDOM SG1 2DX
DEVICE: DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN C
SHEN WEI (USA), INC. 510(k) NO: K033539(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 08-JAN-04
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDERED VINYL EXAMINATION GLOVES
SHEN WEI (USA), INC. 510(k) NO: K033692(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 16-JAN-04
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL EXAMINATION GLOVES
SHEN WEI (USA), INC. 510(k) NO: K033693(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 16-JAN-04
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K040060(TRADITIONAL)
ATTN: PATRICK J LYNCH PHONE NO : 425-557-1825
22010 S.E. 51ST ST. SE DECISION MADE: 28-JAN-04
ISSAQUAH, WA 98029-7298 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K033675(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 15-JAN-04
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SK MED ME202 MONITORING MIXER
SK MED 510(k) NO: K031860(TRADITIONAL)
ATTN: DIPAK GHOSH PHONE NO : 818-776-1325
16000 SHERMAN WAY #224 SE DECISION MADE: 21-JAN-04
VAN NUYS, CA 91406 510(k) STATEMENT
DEVICE: SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
SMART GLOVE CORP. SDN BHD 510(k) NO: K033683(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 08-JAN-04
SEMENTA, JALAN KAPAR 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: MODIFICATION TO JET-X HA COATED HALF PINS
SMITH & NEPHEW, INC. 510(k) NO: K033289(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 13-JAN-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
SMITHS MEDICAL MD, INC. 510(k) NO: K033686(TRADITIONAL)
ATTN: PATRICIA A LAFORTE PHONE NO : 651-628-7267
1265 GREY FOX ROAD SE DECISION MADE: 23-JAN-04
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGYTEX MESH
SOFRADIM PRODUCTION 510(k) NO: K033376(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 15-JAN-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
SONTRA MEDICAL INC. 510(k) NO: K023713(TRADITIONAL)
ATTN: ALBERT FARINHA PHONE NO : 617-494-5337
58 CHARLES ST. SE DECISION MADE: 28-JAN-04
CAMBRIDGE, MA 02141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEEX SYSTEM FOR URINARY INCONTINENCE
SPECIALITIES REMEEX INTERNATIONAL,510(k) NO: K033310(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
7307 GLOUCHESTER DRIVE SE DECISION MADE: 15-JAN-04
EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIRAZ-JAVA SPINAL FIXATION SYSTEM
SPINE NEXT AMERICA 510(k) NO: K033772(TRADITIONAL)
ATTN: DIANE JOHNSON PHONE NO : 410-409-8276
104 GREENWOOD CREEK ROAD SE DECISION MADE: 27-JAN-04
QUEENSTOWN, MD 21658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC. 510(k) NO: K033508(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. SE DECISION MADE: 27-JAN-04
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: DUREX PLAY LUBRICANT
SSL AMERICAS, INC. 510(k) NO: K032124(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 770-582-2222
3585 ENGINEERING DR. SE DECISION MADE: 16-JAN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K032303(TRADITIONAL)
ATTN: JEAN W SHEPPARD PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 16-JAN-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNPEX TECHNOLOGIES MODEL SE03
SUNPEX TECHNOLOGY CO., LTD. 510(k) NO: K033019(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVE. SE DECISION MADE: 22-JAN-04
BALTIMORE, MD 21230 510(k) STATEMENT
DEVICE: PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
SURGIN SURGICAL INSTRUMENTATION, I510(k) NO: K033182(TRADITIONAL)
ATTN: DON HAAR PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE SE DECISION MADE: 30-JAN-04
TUSTIN, CA 92680 510(k) STATEMENT
DEVICE: AC APPLICATOR, AURORA AC
SYNERON MEDICAL LTD. 510(k) NO: K032514(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 674 04616
POB 550 SE DECISION MADE: 27-JAN-04
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMORY CARDIAC TOOLBOX VERSION 2.6
SYNTERMED, INC. 510(k) NO: K040141(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
3340 PEACHTREE RD NE SE DECISION MADE: 30-JAN-04
SUITE 1800 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30326 THIRD PARTY REVIEW
DEVICE: SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
SYNTHES (USA) 510(k) NO: K033556(TRADITIONAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 13-JAN-04
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T.S. MEDICAL CIRCUMCISION CLAMP
T.S. MEDICAL 510(k) NO: K033403(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203
55 NORTHERN BLVD. SE DECISION MADE: 22-JAN-04
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: FORCE FIBER
TELEFLEX MEDICAL 510(k) NO: K033654(TRADITIONAL)
ATTN: LYNN MATOS PHONE NO : 508-677-6600
600 AIRPORT RD. SE DECISION MADE: 15-JAN-04
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS
THE BINDING SITE, LTD. 510(k) NO: K033811(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 30-JAN-04
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: POWERSTAND STAND-UP WHEELCHAIR
THE STANDING CO., INC. 510(k) NO: K032101(TRADITIONAL)
ATTN: MICHAEL A OLVERA PHONE NO : 989-746-9100
1916 S. NIAGARA ST., SUITE A SE DECISION MADE: 22-JAN-04
SAGINAW, MI 48602 510(k) STATEMENT
DEVICE: SECUMAX BLOOD COLLECTION SYSTEM
TIGER MEDITECH INCORPORATED 510(k) NO: K032141(TRADITIONAL)
ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918
2064 TAMARIN DR. SE DECISION MADE: 28-JAN-04
COLUMBUS, OH 43235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
TRANS1, INC. 510(k) NO: K032891(TRADITIONAL)
ATTN: W. ALLEN PUTNAM PHONE NO : 952-474-7351
6285 CHASKA ROAD SE DECISION MADE: 15-JAN-04
EXCELSIOR, MN 55331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROCHAMBER MAX VALVED HOLDING CHAMBER
TRUDELL MEDICAL INTL. 510(k) NO: K032972(SPECIAL)
ATTN: TOM HOLBROOK PHONE NO : 519 455 7060
725 THIRD ST. SE DECISION MADE: 14-JAN-04
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: E.P.T. PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K033658(SPECIAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 16-JAN-04
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: SPIRIT 5000 CARDIAC COIL
USA INSTRUMENTS, INC. 510(k) NO: K033490(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-995-8572
1515 DANNER DR. SE DECISION MADE: 09-JAN-04
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
VARIAN INC 510(k) NO: K033659(TRADITIONAL)
ATTN: LORNA GAMBOA PHONE NO : 949-639-5415
25200 COMMERCENTRE DR. SE DECISION MADE: 06-JAN-04
LAKE FOREST, CA 92630-8810 510(k) STATEMENT
DEVICE: ONTRAK TESTCUP II AND ONSITE CUPKIT
VARIAN INC 510(k) NO: K033902(SPECIAL)
ATTN: LORNA GAMBOA PHONE NO : 949-639-5415
25200 COMMERCENTRE DR. SE DECISION MADE: 20-JAN-04
LAKE FOREST, CA 92630-8810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADI MANUAL RESUSCITATOR
VEDI CORP. 510(k) NO: K030864(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 214-632-0636
6833 SAINT LAWRENCE ST. SE DECISION MADE: 30-JAN-04
PLANO, TX 75024 510(k) STATEMENT
DEVICE: VNUS VESSEL AND TISSUE COAGULATION SYSTEM
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K033547(TRADITIONAL)
ATTN: SAM NANAVATI PHONE NO : 408-473-1140
2200 ZANKER RD., SUITE F SE DECISION MADE: 07-JAN-04
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
VYSIS 510(k) NO: K033982(SPECIAL)
ATTN: KERRY J FLOM PHONE NO : 630-271-7083
3100 WOODCREEK DRIVE SE DECISION MADE: 22-JAN-04
DOWNERS GROVE, IL 60515-5400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHOSCOPY PUMP A115
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K033927(SPECIAL)
ATTN: SUSANNE RAAB PHONE NO : 703-299-0523
368 NORTH ASAPH STREET SE DECISION MADE: 15-JAN-04
ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLVE RADIAL PLATE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K033456(TRADITIONAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 28-JAN-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE DOUBLE HIGH INSERT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K033890(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 15-JAN-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
ZIMMER, INC. 510(k) NO: K033363(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 16-JAN-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 228
TOTAL WITH SUMMARIES 175
TOTAL WITH STATEMENTS 53
Updated February 6, 2004
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