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510(k)s Final Decisions Rendered for January 2000 |
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DEVICE: EMS KERMIT
(EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K992504(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 27-JAN-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M TR SYSTEM
3M CO. 510(k) NO: K992489(TRADITIONAL)
ATTN: LAEL J PICKETT PHONE NO : 651-733-3594
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 11-JAN-00
ST. PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNEA - LS LOW-SPEED HANDPIECE
A-DEC, INC. 510(k) NO: K993526(TRADITIONAL)
ATTN: PATRICK RIDENOUR PHONE NO : 503-537-2756
2601 CRESTVIEW DR. SE DECISION MADE: 11-JAN-00
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
ACCULASE, INC. 510(k) NO: K992914(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 760-602-3300
2431 IMPALA DRIVE SE DECISION MADE: 27-JAN-00
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON ONE STEP HOME PREGNANCY TEST STRIP
ACON LABORATORIES, INC. 510(k) NO: K993483(TRADITIONAL)
ATTN: NORA C.R. YORK PHONE NO : 858-535-2030
11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 20-JAN-00
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED SUTURE ANCHOR
ACUMED, INC. 510(k) NO: K993657(TRADITIONAL)
ATTN: SHARI JEFFERS PHONE NO : 503-627-9957
10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 13-JAN-00
BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991391(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO SE DECISION MADE: 10-JAN-00
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: AESCULAP VASCULAR INSTRUMENTS
AESCULAP, INC. 510(k) NO: K992053(TRADITIONAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 650-642-5072
1000 GATEWAY BLVD. SE DECISION MADE: 13-JAN-00
SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOCON SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K993551(TRADITIONAL)
ATTN: LIA S JONES PHONE NO : 650-876-7000
1000 GATEWAY BLVD. SE DECISION MADE: 13-JAN-00
SOUTH SAN FRANCISCO, CA 94080-7030510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENAFLOW SYSTEM, MODEL 30A
AIRCAST, INC. 510(k) NO: K992454(TRADITIONAL)
ATTN: STEPHEN KENNEY PHONE NO : 908-273-6349
92 RIVER RD. SE DECISION MADE: 13-JAN-00
SUMMIT, NJ 07902 510(k) STATEMENT
DEVICE: AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K993522(TRADITIONAL)
ATTN: JOAN ZACHAROPOULOS PHONE NO : 914-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 10-JAN-00
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K992767(ABBREVIATED)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 10-JAN-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERTORS SURGICAL DRAPES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K993795(TRADITIONAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 12-JAN-00
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
ALPHA OMEGA LTD. 510(k) NO: K993622(TRADITIONAL)
ATTN: SHOSHANA S FRIEDMN PHONE NO : 972 771 8130
117 AHUZAH ST. SE DECISION MADE: 24-JAN-00
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
ALPHATEC MFG., INC. 510(k) NO: K993873(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 760-779-8250
42-160 STATE ST. SE DECISION MADE: 03-JAN-00
PALM DESERT, CA 92211-5148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMLOG CYLINDER IMPLANT SYSTEM
ALTATEC BIOTECHNOLOGIES 510(k) NO: K000065(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: CAMLOG SCREW IMPLANT SYSTEM
ALTATEC BIOTECHNOLOGIES 510(k) NO: K000099(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: CAMLOG ROOTFORM IMPLANT SYSTEM
ALTATEC BIOTECHNOLOGIES 510(k) NO: K000100(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 28-JAN-00
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: A-22 HEMODIALYZER
ALTHIN MEDICAL AB 510(k) NO: K992563(TRADITIONAL)
ATTN: LARS-OLOF SANDBERB PHONE NO : 464-577-5900
FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00
RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AF-180 HEMODIALYZER
ALTHIN MEDICAL AB 510(k) NO: K992564(TRADITIONAL)
ATTN: LARS-OLOF SANDBERG PHONE NO : 464-577-5900
FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00
RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AF-150 HEMODIALYZER
ALTHIN MEDICAL AB 510(k) NO: K992566(TRADITIONAL)
ATTN: LARS-OLOF SANDBERG PHONE NO : 464-577-5900
FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00
RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AF-220 HEMODIALYZER
ALTHIN MEDICAL AB 510(k) NO: K992573(TRADITIONAL)
ATTN: LARS-OLOF SANDBERB PHONE NO : 464-577-5900
FRIDHEMSVAGEN 15 SE DECISION MADE: 18-JAN-00
RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADID DRUG SCREEN 5-PANEL TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K993151(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 10-JAN-00
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CAN
AMERICAN BIO MEDICA CORP. 510(k) NO: K993961(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 800-227-1243
122 SMITH ROAD SE DECISION MADE: 24-JAN-00
KINDERHOOK, NY 12106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABI VEST AIRWAY CLEARANCE SYSTEM
AMERICAN BIOSYSTEMS, INC. 510(k) NO: K993629(TRADITIONAL)
ATTN: ERIC J LARSON PHONE NO : 651-234-1211
20 YORKTON CT. SE DECISION MADE: 21-JAN-00
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIVA SYSTEM, MODEL SL1010
AMERICAN TELECARE, INC. 510(k) NO: K993550(TRADITIONAL)
ATTN: CHARLES RICHARD ABRUSCATO PHONE NO : 612-897-0000
7640 GOLDEN TRIANGLE DR. SE DECISION MADE: 13-JAN-00
EDEN PRAIRIE, MN 55344-3732 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
AMSINO INTL., INC. 510(k) NO: K992719(TRADITIONAL)
ATTN: RICHARD Y LI PHONE NO : 909-626-3783
833 TOWNE CENTER DR. SE DECISION MADE: 12-JAN-00
POMONA, CA 91767 510(k) STATEMENT
DEVICE: AMUKIN D
AMUCHINA INTL., INC. 510(k) NO: K992016(TRADITIONAL)
ATTN: LUDOVICO GIAVOTTO PHONE NO : 301-330-7597
8-8 METROPLITAN CT. SE DECISION MADE: 10-JAN-00
GAITHERSBURG, MD 20878 510(k) STATEMENT
DEVICE: AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
AMYLIOR INC. 510(k) NO: K994072(TRADITIONAL)
ATTN: SYLVAIN DUGAS PHONE NO : 514 453 0311
6 ANTOINE-HENAULT SE DECISION MADE: 13-JAN-00
NOTE-DAME OF ILE PERROT,QUEBEC, CA510(k) STATEMENT
DEVICE: AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FR
AMYLIOR INC. 510(k) NO: K994107(TRADITIONAL)
ATTN: SYLVAIN DUGAS PHONE NO : 514 453 0311
6 ANTOINE-HENAULT SE DECISION MADE: 13-JAN-00
NOTE-DAME OF ILE PERROT,QUEBEC, CA510(k) STATEMENT
DEVICE: THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVE
ANSELL PERRY INC. 510(k) NO: K993857(TRADITIONAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 31-JAN-00
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
ARTHREX, INC. 510(k) NO: K990340(TRADITIONAL)
ATTN: VERNON C BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 28-JAN-00
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
ARTHREX, INC. 510(k) NO: K990987(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 13-JAN-00
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K994330(SPECIAL)
ATTN: CHRISTINE MORGIDA PHONE NO : 508-653-0603
2 VISION DR. SE DECISION MADE: 18-JAN-00
NATICK, MA 01760-2059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
ATRIUM MEDICAL CORP. 510(k) NO: K992991(TRADITIONAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 27-JAN-00
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: AUTOMATED OPHTHALMICS SOFTIPS
AUTOMATED OPHTHALMICS, INC. 510(k) NO: K992998(TRADITIONAL)
ATTN: NORMAN BICKMAN PHONE NO : 800-242-5602
8253 GLEMAR ROAD SE DECISION MADE: 10-JAN-00
ELLICOTT, MD 21043 510(k) STATEMENT
DEVICE: MODIFICATION TO BONE ANCHOR AND KIT (BAK)
AXYA MEDICAL, INC. 510(k) NO: K994313(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 13-JAN-00
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: CELSITE, MODELS ST401L, ST405L
B. BRAUN/MCGAW 510(k) NO: K994111(SPECIAL)
ATTN: VALERIE LEWIS PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 03-JAN-00
ALLENTOWN, PA 18103-9341 510(k) STATEMENT
DEVICE: VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
BAUSCH & LOMB, INC. 510(k) NO: K993039(TRADITIONAL)
ATTN: VANADA JOHNSON PHONE NO : 636-226-3182
3365 TREE COURT INDUSTRIAL BLV SE DECISION MADE: 07-JAN-00
ST. LOUIS, MO 63122-6694 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS HYBRITECH FREE PSA QC, MODEL 37219
BECKMAN COULTER, INC. 510(k) NO: K993210(TRADITIONAL)
ATTN: MICHEL GUST PHONE NO : 612-368-7688
1000 LAKE HAZELTINE DR. SE DECISION MADE: 05-JAN-00
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
BECKMAN COULTER, INC. 510(k) NO: K993954(TRADITIONAL)
ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-337 SE DECISION MADE: 11-JAN-00
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS HYBRITECH PSA QC, MODEL 37209
BECKMAN COULTER, INC. 510(k) NO: K994200(TRADITIONAL)
ATTN: MICHELE GUST PHONE NO : 612-368-7688
1000 LAKE HAZELTINE DR. SE DECISION MADE: 18-JAN-00
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS OSTASE QC
BECKMAN COULTER, INC. 510(k) NO: K994277(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 858-621-4583
7330 CARROLL ROAD SE DECISION MADE: 14-JAN-00
SAD DIEGO, CA 92196-9006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
BECKMAN COULTER, INC. 510(k) NO: K994325(TRADITIONAL)
ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 12-JAN-00
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 3
BECKMAN COULTER, INC. 510(k) NO: K994439(TRADITIONAL)
ATTN: MICHELE S GUST PHONE NO : 612-368-7688
1000 LAKE HAZELTINE DR. SE DECISION MADE: 14-JAN-00
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
BELMONT INSTRUMENT CORP. 510(k) NO: K983866(TRADITIONAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 06-JAN-00
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICR
BESGLOVE MEDICARE SDN. BHD. 510(k) NO: K994082(TRADITIONAL)
ATTN: LEE AIK LIM PHONE NO : 603 825 6361
LOT 6, JALAN P/2A SE DECISION MADE: 28-JAN-00
BANGI INDUSTRIAL ESTATE 510(k) STATEMENT
KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000
DEVICE: THE 4.5MM DIAMETER BICON DENTAL IMPLANT
BICON, INC. 510(k) NO: K994037(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-524-4443
1153 CENTRE STREET SE DECISION MADE: 11-JAN-00
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: FORTOSS-CEMA
BIOCOMPOSITES LTD. 510(k) NO: K993238(TRADITIONAL)
ATTN: JS BRATT PHONE NO : 44 178 2206500
ETRUSCAN ST., ETRURIA SE DECISION MADE: 14-JAN-00
STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE AUTOTAC SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K993493(TRADITIONAL)
ATTN: WINSTON D GREER PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 07-JAN-00
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: MSA-21
BIOMERIDIAN, INC. 510(k) NO: K993824(SPECIAL)
ATTN: JOE GALLOWAY PHONE NO : 801-501-7517
12411 SOUTH 265 WEST SE DECISION MADE: 20-JAN-00
SUITE F 510(k) SUMMARY AVAILABLE FROM FDA
DRAPER, UT 84020
DEVICE: ASCENT KNEE SYSTEM
BIOMET MANUFACTURING, INC. 510(k) NO: K994326(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 07-JAN-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
BIOPRO (M) SDN BHD 510(k) NO: K994043(TRADITIONAL)
ATTN: JAMES H LALE PHONE NO : 603 376 1390
LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 11-JAN-00
HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT
PORT KLANG, MALAYSIA 42000
DEVICE: SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-
BIOSURGICAL CORP. 510(k) NO: K000048(SPECIAL)
ATTN: TERRY LAAS PHONE NO : 925-737-1850
5990 STONERIDGE DRIVE SE DECISION MADE: 31-JAN-00
SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94555
DEVICE: HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
BIRD PRODUCTS CORP. 510(k) NO: K990856(TRADITIONAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255
1100 BIRD CENTER DR. SE DECISION MADE: 11-JAN-00
PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
BOSTON SCIENTIFIC CORP. 510(k) NO: K994252(SPECIAL)
ATTN: ANDREA BOUMIS PHONE NO : 408-895-3625
2710 ORCHARD PKWY. SE DECISION MADE: 04-JAN-00
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIA
BOSTON SCIENTIFIC, TARGET 510(k) NO: K993415(TRADITIONAL)
ATTN: ROXANE BAXTER PHONE NO : 510-624-2105
47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GU
BOSTON SCIENTIFIC, TARGET 510(k) NO: K993417(TRADITIONAL)
ATTN: ROXANE BAXTER PHONE NO : 510-624-2105
47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
BOSTON SCIENTIFIC, TARGET 510(k) NO: K993418(TRADITIONAL)
ATTN: ROXANE BAXTER PHONE NO : 510-624-2105
47900 BAYSIDE PARKWAY SE DECISION MADE: 21-JAN-00
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINLAB STEREOTACTIC ARC
BRAINLAB 510(k) NO: K992916(TRADITIONAL)
ATTN: ERIC LINDQUIST PHONE NO : 650-494-7240
100 MARINE PARKWAY SE DECISION MADE: 11-JAN-00
SUITE 305 510(k) STATEMENT
REDWOOD CITY, CA 94065
DEVICE: COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MOD
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K993900(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 650-428-1600
1400N SHORELINE BLVD. SE DECISION MADE: 28-JAN-00
BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043
DEVICE: MULTIFUNCTION KEITO K5
BUMEDCO INTL., INC. 510(k) NO: K984083(TRADITIONAL)
ATTN: DARROLD GLANVILLE PHONE NO : 651-787-0625
725 TIMBER LANE SE DECISION MADE: 18-JAN-00
SHOREVIEW, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD MEMOTHERM FLEXX BILIARY STENT
C.R. BARD, INC. 510(k) NO: K993392(ABBREVIATED)
ATTN: CAROL VIERLING PHONE NO : 770-385-2347
13183 HARLAND DR. SE DECISION MADE: 06-JAN-00
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD UROFORCE BALLOON DILATION CATHETER
C.R. BARD, INC. 510(k) NO: K993840(ABBREVIATED)
ATTN: ANGELA L BUNN PHONE NO : 770-784-6774
8195 INDUSTRIAL BLVD. SE DECISION MADE: 31-JAN-00
COVINGTON, GA 30209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DUR
C.R. BARD, INC. 510(k) NO: K993892(SPECIAL)
ATTN: MARION GORDON PHONE NO : 978-262-4867
129 CONCORD RD., BLDG. 3 SE DECISION MADE: 06-JAN-00
BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SCLERO LONG PULSE DYE LASER
CANDELA CORP. 510(k) NO: K993671(TRADITIONAL)
ATTN: JOAN CLIFFORD PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 24-JAN-00
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRITERION 40 OR PM 40
CARADYNE, LTD. 510(k) NO: K992101(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 06-JAN-00
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART AECD
CARDIAC SCIENCE, INC. 510(k) NO: K993533(SPECIAL)
ATTN: STAN E TILLMAN PHONE NO : 949-587-0357
16931 MILLIKAN AVE. SE DECISION MADE: 24-JAN-00
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION
CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K993519(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 919-874-6103
5301 DEPARTURE DR. SE DECISION MADE: 14-JAN-00
RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAIN
CASE MEDICAL, INC. 510(k) NO: K991023(TRADITIONAL)
ATTN: LARRY R PILOT PHONE NO : 202-496-7561
1900 K STREET, N.W. SE DECISION MADE: 27-JAN-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO-CARE BRAND HARD SOLUTION
CIBA VISION CORP. 510(k) NO: K993949(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 05-JAN-00
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPVIEW IMAGE ENHANCEMENT SYSTEM
CONTEXTVISION AB 510(k) NO: K993802(TRADITIONAL)
ATTN: CONSTANCE BUNDY PHONE NO : 612-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 18-JAN-00
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS WOUND DRESSING II
COOK BIOTECH, INC. 510(k) NO: K993948(TRADITIONAL)
ATTN: NEAL E FEARNOT PHONE NO : 765-497-3355
3055 KENT AVE. SE DECISION MADE: 06-JAN-00
WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLIPPER DETACHABLE EMBOLIZATION COIL
COOK, INC. 510(k) NO: K993455(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 800-346-2686
925 S. CURRY PIKE SE DECISION MADE: 11-JAN-00
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
CORDIS CORP. 510(k) NO: K993720(TRADITIONAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 18-JAN-00
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY
CORDIS CORP. 510(k) NO: K994156(SPECIAL)
ATTN: CHARLES J RYAN PHONE NO : 908-412-7446
7 POWDERHORN DRIVE SE DECISION MADE: 07-JAN-00
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATW MARKER WIRE STEERABLE GUIDEWIRE
CORDIS CORP. 510(k) NO: K994358(SPECIAL)
ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283
14201 N.W. 60TH AVE. SE DECISION MADE: 13-JAN-00
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENAMEL SCULPT
COSMEDENT, INC. 510(k) NO: K993658(TRADITIONAL)
ATTN: MICHAEL O'MALLEY PHONE NO : 773-989-6844
5419 NORTH SHERIDAN RD. SE DECISION MADE: 18-JAN-00
CHICAGO, IL 60640 510(k) STATEMENT
DEVICE: RENAMEL PACK
COSMEDENT, INC. 510(k) NO: K993659(TRADITIONAL)
ATTN: MICHAEL O'MALLEY PHONE NO : 773-989-6844
5419 NORTH SHERIDAN RD. SE DECISION MADE: 18-JAN-00
CHICAGO, IL 60640 510(k) STATEMENT
DEVICE: INTRAVASCULAR ADMINISTRATION SET
CUSTOM ASSEMBLIES, INC. 510(k) NO: K993463(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 04-JAN-00
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
CYNOSURE, INC. 510(k) NO: K994427(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 18-JAN-00
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA SPIR
CYNOSURE, INC. 510(k) NO: K994437(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 18-JAN-00
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED D-DIMER
DADE BEHRING, INC. 510(k) NO: K992957(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 28-JAN-00
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: BEHRING COAGULATION SYSTEM (BCS)
DADE BEHRING, INC. 510(k) NO: K992959(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 11-JAN-00
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K994114(TRADITIONAL)
ATTN: ROBIN O NORRIS PHONE NO : 302-631-7446
P.O. BOX 6101 SE DECISION MADE: 20-JAN-00
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K994115(TRADITIONAL)
ATTN: ROBIN O NORRIS PHONE NO : 302-631-7446
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 28-JAN-00
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MICROSTREP PLUS PANEL, VANCOMYCIN
DADE MICROSCAN, INC. 510(k) NO: K983953(TRADITIONAL)
ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-8183
1584 ENTERPRISE BLVD. SE DECISION MADE: 14-JAN-00
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
DADE MICROSCAN, INC. 510(k) NO: K993679(TRADITIONAL)
ATTN: TREVOR WALL PHONE NO : 916-374-3222
2040 ENTERPRISE BLVD. SE DECISION MADE: 14-JAN-00
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
DATASCOPE CORP. 510(k) NO: K993531(ABBREVIATED)
ATTN: SUSAN E MANDY PHONE NO : 201-967-2229
580 WINTERS AVENUE SE DECISION MADE: 13-JAN-00
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERGOGOLD
DEGUSSA - NEY DENTAL, INC. 510(k) NO: K993897(TRADITIONAL)
ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886
1065 S.W. 30TH AVE. SE DECISION MADE: 10-JAN-00
DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT
DEVICE: DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
DEPUY, INC. 510(k) NO: K993465(TRADITIONAL)
ATTN: ARLENE C SAULL PHONE NO : 219-371-4904
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-JAN-00
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K993920(TRADITIONAL)
ATTN: KAREN CALLBECK PHONE NO : 902 566 1396
16 MCCARVILLE STREET SE DECISION MADE: 18-JAN-00
WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT
CHARLOTTETOWN, P.E.I., CANADA C1E 2A6
DEVICE: IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992632(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 27-JAN-00
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992634(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 20-JAN-00
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K994085(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 28-JAN-00
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOS-A-SCOPE
DISPOS-A-SCOPE 510(k) NO: K993738(TRADITIONAL)
ATTN: LAUREL NICHOLAS PHONE NO : 208-743-4567
315 SKYLINE DRIVE SE DECISION MADE: 06-JAN-00
LEWISTON, ID 83501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON 900
DYNATRONICS CORP. 510(k) NO: K993919(TRADITIONAL)
ATTN: JOHN S RAMSEY PHONE NO : 801-568-7000
7030 PARK CENTRE DR. SE DECISION MADE: 03-JAN-00
SALT LAKE CITY, UT 84121 510(k) STATEMENT
DEVICE: REVELATION POROUS HIP STEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K994070(SPECIAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 20-JAN-00
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSTYLET MODELS EC0010, EC0020
ENDOCARDIAL SOLUTIONS, INC. 510(k) NO: K993376(TRADITIONAL)
ATTN: JAMES BULLOCK PHONE NO : 651-523-6928
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 05-JAN-00
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EC-7701 FLUID WARMING CABINET
ENTHERMICS MEDICAL SYSTEMS, INC. 510(k) NO: K993797(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255
1900 K STREET NW SE DECISION MADE: 20-JAN-00
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992811(ABBREVIATED)
ATTN: KRISTA OAKES PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300 SE DECISION MADE: 18-JAN-00
PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
ESC MEDICAL SYSTEMS LTD. 510(k) NO: K991935(TRADITIONAL)
ATTN: ZVI LADIN PHONE NO : 781-444-8446
250 FIRST AVENUE SE DECISION MADE: 27-JAN-00
NEEDHAM, MA 02194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPREGUM GARANT L DUOSOFT
ESPE DENTAL AG 510(k) NO: K994190(TRADITIONAL)
ATTN: ANDRERAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 27-JAN-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPREGUM PENTA M MONOSOFT
ESPE DENTAL AG 510(k) NO: K994192(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 28-JAN-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPREGUM PENTA DUOSOFT
ESPE DENTAL AG 510(k) NO: K994193(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 28-JAN-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KETAC-MOLAR QUICK
ESPE DENTAL AG 510(k) NO: K994251(SPECIAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 03-JAN-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
ETHICON, INC. 510(k) NO: K994418(SPECIAL)
ATTN: GREGORY JONES PHONE NO : 908-218-2481
P.O. BOX 151, ROUTE 22 SE DECISION MADE: 24-JAN-00
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM CO
EXACTECH, INC. 510(k) NO: K993736(TRADITIONAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 20-JAN-00
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNA ABUTMENT
FACTOR, II, INC. 510(k) NO: K984297(TRADITIONAL)
ATTN: JOHN D MCFALL PHONE NO : 520-537-8387
1972 FOREST AVE. SE DECISION MADE: 28-JAN-00
LAKESIDE, AZ 85929 510(k) STATEMENT
DEVICE: FAS ENDOLUMINAL BRUSH
FAS MEDICAL LTD. 510(k) NO: K993614(TRADITIONAL)
ATTN: LYNNE ARONSON PHONE NO : 303-697-8198
PO BOX 219 SE DECISION MADE: 18-JAN-00
INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTE
FLEXITECH SDN. BHD. 510(k) NO: K994354(TRADITIONAL)
ATTN: Y. F HEW PHONE NO : 603 392 0188
LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 31-JAN-00
MERU 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 41050
DEVICE: INSTACHECK MULTI-DRUG THC/COC TEST, MODEL 200C; INSTACHECK MULTI
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K993863(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 27-JAN-00
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: FRIALIT-2 BONE PROFILER
FRIADENT GMBH 510(k) NO: K993560(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 10-JAN-00
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO DQM 200
GAMBRO HEALTHCARE 510(k) NO: K990039(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018
1185 OAK ST. SE DECISION MADE: 27-JAN-00
LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMAGEM SCINTILLATION CAMERA
GAMMA MEDICA 510(k) NO: K993813(TRADITIONAL)
ATTN: BRADLEY E PATT PHONE NO : 818-709-2468
19355 BUSINESS CENTER DR., SE DECISION MADE: 18-JAN-00
SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
NORTHRIDGE, CA 91324
DEVICE: FUJI II LC CAPSULE
GC AMERICA, INC. 510(k) NO: K993973(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 11-JAN-00
CHICAGO, IL 60658 510(k) STATEMENT
DEVICE: AROMA FINE (NORMAL AND FAST SET)
GC AMERICA, INC. 510(k) NO: K994077(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 27-JAN-00
CHICAGO, IL 60658 510(k) STATEMENT
DEVICE: HEMOSITE TEST SYSTEM
GDS TECHNOLOGY, INC. 510(k) NO: K994073(TRADITIONAL)
ATTN: KEITH CRAWFORD PHONE NO : 219-264-7384
25235 LEER DRIVE SE DECISION MADE: 14-JAN-00
P.O. BOX 473 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46515
DEVICE: CLINICAL BLOOD GAS MIXTURE
GENERAL AIR SERVICE AND SUPPLY 510(k) NO: K993789(TRADITIONAL)
ATTN: MICHAEL FISHER PHONE NO : 303-892-7003
6330 COLORADO BLVD. SE DECISION MADE: 10-JAN-00
COMMERCE CITY, CO 80022 510(k) STATEMENT
DEVICE: ELECTROSURGICAL ELECTRODE FAMILY
GENESIS MEDICAL, INC. 510(k) NO: K992045(TRADITIONAL)
ATTN: THOMAS WEHMAN PHONE NO : 408-522-8690
524 WEDDEL DRIVE, SUITE 4 SE DECISION MADE: 27-JAN-00
SUNNYVALE, CA 94089 510(k) STATEMENT
DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
GLOVCO (M) SDN. BHD. 510(k) NO: K994013(TRADITIONAL)
ATTN: TAN CHWEE HOCK PHONE NO : 603 391 3888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 20-JAN-00
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
GLOVE SOURCE, INC. 510(k) NO: K994064(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 626-913-1798
889 SOUTH AZUSA AVE. SE DECISION MADE: 28-JAN-00
CITY OF INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE LIGHT CURING UNIT
GREGORY S. JACOB, D.D.S. 510(k) NO: K994048(TRADITIONAL)
ATTN: GREGORY S JACOB PHONE NO : 847-298-8954
9672 READING CIRCLE SE DECISION MADE: 13-JAN-00
DES PLAINS, IL 60016 510(k) STATEMENT
DEVICE: EIS DYNAMIC MEMORY STAPLES SYSTEM
GROUPE LEPINE 510(k) NO: K991962(TRADITIONAL)
ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL SE DECISION MADE: 10-JAN-00
SUITE 203 510(k) STATEMENT
SARASOTA, FL 34326
DEVICE: RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PER
GUIDANT CORP. 510(k) NO: K993639(TRADITIONAL)
ATTN: SUSAN SILAVIN PHONE NO : 408-235-3127
3200 LAKESIDE DR. SE DECISION MADE: 27-JAN-00
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K993793(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 12-JAN-00
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: GYNECARE VERSAPOINT G-VAP ELECTRODE
GYNECARE, INC. 510(k) NO: K992901(TRADITIONAL)
ATTN: GREGORY JONES PHONE NO : 908-218-2481
P.O. BOX 151 SE DECISION MADE: 18-JAN-00
SOMMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDYDISK DOXYCYCLINE, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K994051(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 10-JAN-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK AZTREONAM, 30MCG
HARDY DIAGNOSTICS 510(k) NO: K994063(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 14-JAN-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDY DISK AMPICILLIN/SULBACTAM
HARDY DIAGNOSTICS 510(k) NO: K994067(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 14-JAN-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HARDYDISK IMIPENEM, 10MCG
HARDY DIAGNOSTICS 510(k) NO: K994132(TRADITIONAL)
ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 18-JAN-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HP M2376A DEVICE LINK SYSTEM
HEWLETT-PACKARD CO. 510(k) NO: K993587(TRADITIONAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 20-JAN-00
ANDOVER, MA 01810-1085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MON
HEWLETT-PACKARD GMBH 510(k) NO: K992273(ABBREVIATED)
ATTN: EGON PFEIL PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140 SE DECISION MADE: 28-JAN-00
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CITATION TMZF HA STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993768(TRADITIONAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 21-JAN-00
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABY DOPPLEX 4000, MODEL BD 4000
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K990569(TRADITIONAL)
ATTN: AUDREY A WITCO PHONE NO :
227 RT. 33 EAST SE DECISION MADE: 24-JAN-00
MANALAPAN, NJ 07726-8362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUBING EXTENSION SET
HURRICANE MEDICAL 510(k) NO: K993361(TRADITIONAL)
ATTN: DAVID A CLAPP PHONE NO : 941-751-0588
2331K 63RD AVE. EAST SE DECISION MADE: 04-JAN-00
BRADENTON, FL 34203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
ICON INTL., LLC. 510(k) NO: K993461(TRADITIONAL)
ATTN: GERALD S AUSLANDER PHONE NO : 636-527-2707
300 OZARK TRAIL DRIVE #207C SE DECISION MADE: 03-JAN-00
ELLISVILLE, MO 63011 510(k) STATEMENT
DEVICE: HANNAH WIRELESS VITAL SIGNS MONITOR
ILIFE SYSTEMS, INC. 510(k) NO: K991087(TRADITIONAL)
ATTN: JOSHUA A ADLER PHONE NO : 214-365-7400
5910 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 12-JAN-00
SUITE 1775 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75206
DEVICE: MRI EQUIPMENT COVER
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K993682(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 407-757-8990
2290 W. EAU GALLIE BLVD SE DECISION MADE: 20-JAN-00
SUITE 210 510(k) STATEMENT
MELBOURNE, FL 32935
DEVICE: WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
INDUSTRIELLE ENTWICKLUNG MEDIZINTE510(k) NO: K991545(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001
11641 RED HIBISCUS DRIVE SE DECISION MADE: 19-JAN-00
BONITA SPRINGS, FL 34135 510(k) STATEMENT
DEVICE: HOT SHOT FLUID WARMER IV FLUIDS
INFRA-MED TECHNOLOGIES, INC. 510(k) NO: K992258(TRADITIONAL)
ATTN: BERTRAM J HUDSON PHONE NO : 972-355-9700
3535 FIREWHEEL DRIVE, SUITE A SE DECISION MADE: 12-JAN-00
FLOWER MOUND, TX 75028-2628 510(k) STATEMENT
DEVICE: TITAN RC TACK
INNOVASIVE DEVICES, INC. 510(k) NO: K994269(SPECIAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229
734 FOREST ST. SE DECISION MADE: 10-JAN-00
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTE
INNOVATIVE GLOVES CO; LTD 510(k) NO: K993567(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 442 8408
11 CHOTEVITTAYAKUL 3 ROAD SE DECISION MADE: 12-JAN-00
KHOHONG, HATYAI,SONGKHLA, THAILAND510(k) STATEMENT
DEVICE: QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
INOVA DIAGNOSTICS, INC. 510(k) NO: K994004(TRADITIONAL)
ATTN: GARY L NORMAN PHONE NO : 619-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 27-JAN-00
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K991355(TRADITIONAL)
ATTN: TRICIA WOOD PHONE NO : 412-854-1133
2990 INDUSTRIAL BLVD. SE DECISION MADE: 27-JAN-00
BETHEL PARK, PA 15102 510(k) STATEMENT
DEVICE: INTER-OS BONE GENERATOR
INTER-OS TECHNOLOGIES, L.L.C. 510(k) NO: K993869(TRADITIONAL)
ATTN: RANDOLPH C ROBINSON PHONE NO : 303-699-7970
7144 S. CHAPPARAL CIR. E. SE DECISION MADE: 19-JAN-00
AURORA, CO 80016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
INTERCONTINENTAL NEW TECHNOLOGIES,510(k) NO: K992256(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 11-JAN-00
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBC FLOGUARD, MODEL 6050
INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K992785(TRADITIONAL)
ATTN: H. DAVID SHOCKLEY, JR PHONE NO : 512-326-3244
4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 14-JAN-00
SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744
DEVICE: URINALYSIS REAGENT STRIPS (10 PARAMETERS)
INTERNATIONAL NEWTECH DEVELOPMENT,510(k) NO: K993850(TRADITIONAL)
ATTN: DENNIS S.L. HONG PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 03-JAN-00
DELTA, B.C., CANADA V3M 6S7 510(k) STATEMENT
DEVICE: MD 420/440/460/470/480/490
ISOPURE CORP. 510(k) NO: K993200(TRADITIONAL)
ATTN: KEVIN C GILLESPIE PHONE NO : 502-267-7873
11700 COMMONWEALTH DRIVE SE DECISION MADE: 24-JAN-00
SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA
LOUISVILLE, KY 40299
DEVICE: ROTARY MASTER
J. MORITA USA, INC. 510(k) NO: K992648(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 31-JAN-00
SUITE 500 NORTH 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: INFRARED EAR THERMOMETER, MODEL KI-8120
K-JUMP HEALTH CO., LTD. 510(k) NO: K984551(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN STREET, N.W. SE DECISION MADE: 14-JAN-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. PLUS
KINETIC CONCEPTS, INC. 510(k) NO: K992448(TRADITIONAL)
ATTN: JUDITH A HARBOUR PHONE NO : 210-255-4468
P.O. BOX 659508 SE DECISION MADE: 18-JAN-00
SAN ANTONIO, TX 78265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITESABER 2000
LASER DENTAL INNOVATIONS 510(k) NO: K993942(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 18-JAN-00
SUIYE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523
DEVICE: ULTRASHAPER KERATOME
LASERSIGHT TECHNOLOGIES, INC. 510(k) NO: K990227(TRADITIONAL)
ATTN: MICHAEL P DAYTON PHONE NO : 407-678-9900
3300 UNIVERSITY BLVD., #140 SE DECISION MADE: 31-JAN-00
WINTER PARK, FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLIPO XENON CURING LIGHT
LOKKI 510(k) NO: K994028(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
344 ANNABELLE POINT RD SE DECISION MADE: 12-JAN-00
CENTERVILLE, MA 02632 510(k) STATEMENT
DEVICE: TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
LONGBEST (XIAMEN) BALLS CO., LTD 510(k) NO: K993847(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
NO. 18 CHIN LIU ST SE DECISION MADE: 18-JAN-00
SHIAUKANG DIST. 510(k) STATEMENT
KAOHSIUNG, CHINA (TAIWAN)
DEVICE: TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE
LONGBEST (XIAMEN) BALLS CO., LTD 510(k) NO: K993849(TRADITIONAL)
ATTN: CHIEN LIN PHONE NO : 773-327-2054
NO. 18 CHIN LIU ST SE DECISION MADE: 18-JAN-00
SHIAUKANG DIST. 510(k) STATEMENT
KAOHSIUNG, CHINA (TAIWAN)
DEVICE: LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBR
LPG USA, INC. 510(k) NO: K990445(TRADITIONAL)
ATTN: JOCELYNE ROLLAND PHONE NO : 954-569-5005
3101 NORTH FEDERAL HWY. #301 SE DECISION MADE: 18-JAN-00
FORT LAUDERDALE, FL 33306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGSTIM RAPID
MAGSTIM CORPORATION US 510(k) NO: K992911(TRADITIONAL)
ATTN: REZA JALINOUS PHONE NO : 888-624-7846
730 FIFTH AVE. 9TH FLOOR SE DECISION MADE: 07-JAN-00
NEW YORK, NY 10019 510(k) STATEMENT
DEVICE: MANUAL WHEELCHAIR
MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K994185(TRADITIONAL)
ATTN: SCOTT SCHWEISS PHONE NO : 281-398-9365
18206 MANCE CT. SE DECISION MADE: 13-JAN-00
HOUSTON, TX 77094 510(k) STATEMENT
DEVICE: THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
MDS 510(k) NO: K992727(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 18-JAN-00
NEW YORK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
MEDI-MAN REHABILITATION PRODUCTS I510(k) NO: K992779(TRADITIONAL)
ATTN: JOHN T MOGENSEN PHONE NO : 905 565 1480
6200 TOMKEN ROAD SE DECISION MADE: 13-JAN-00
MISSISSAUGA, ONTARIO, CANADA L5T 1510(k) STATEMENT
DEVICE: SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON AMERICA, INC. 510(k) NO: K000030(TRADITIONAL)
ATTN: GARY J ALLESBROOK PHONE NO : 925-201-1954
6616 OWENS DR. SE DECISION MADE: 19-JAN-00
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISYSTEMS BUTTONHOLE NEEDLE SETS
MEDISYSTEMS CORP. 510(k) NO: K990803(TRADITIONAL)
ATTN: LARRY R PILOT PHONE NO : 202-496-7500
1900 K STREET, N.W. SE DECISION MADE: 06-JAN-00
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUIBAND DENTAL
MEDLOGIC GLOBAL CORP. 510(k) NO: K993556(TRADITIONAL)
ATTN: STEPHEN J TAMSETT PHONE NO : 800-625-6442
4815 LIST DR., SUITE 111 SE DECISION MADE: 03-JAN-00
COLORADO SPRINGS, CO 80919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K994208(SPECIAL)
ATTN: MARIE HOLM PHONE NO : 612-391-9000
7611 NORTHLAND DR. SE DECISION MADE: 13-JAN-00
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTE
MEDTRONIC, INC. 510(k) NO: K994331(SPECIAL)
ATTN: NORA K HADDING PHONE NO : 612-514-9500
4000 LEXINGTON AVE. N SE DECISION MADE: 21-JAN-00
SHOREVIEW, MN 55126-2983 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYS
MEGA ELECTRONICS LTD. 510(k) NO: K993411(TRADITIONAL)
ATTN: DAVID MAHONEY PHONE NO : 413-525-6313
200 NORTH MAIN STREET SE DECISION MADE: 10-JAN-00
SOUTH BUILDING, SUITE 6 510(k) SUMMARY AVAILABLE FROM FDA
EAST LONGMEADOW, MA 01028
DEVICE: VACLOK SYRINGE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K994253(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 05-JAN-00
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993400(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 718-597-3999
1470 OUTLOOK AVE. SE DECISION MADE: 06-JAN-00
BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEGMENTED VAGINAL APPLICATOR
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993472(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 718-597-3999
1470 OUTLOOK AVE. SE DECISION MADE: 12-JAN-00
BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
MICOMED GMBH 510(k) NO: K991862(TRADITIONAL)
ATTN: CHARMAINE HENDERSON PHONE NO : 714-525-8441
511 CATALINA ROAD SE DECISION MADE: 13-JAN-00
FULLERTON, CA 92835 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI SM/RNP TEST
MICRO DETECT, INC. 510(k) NO: K993635(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 10-JAN-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI SS-A TEST
MICRO DETECT, INC. 510(k) NO: K993636(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 10-JAN-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI RF TEST
MICRO DETECT, INC. 510(k) NO: K993843(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBO
MICRO DETECT, INC. 510(k) NO: K993971(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDI SM TEST
MICRO DETECT, INC. 510(k) NO: K994029(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 11-JAN-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
MICRO THERAPEUTICS, INC. 510(k) NO: K993672(SPECIAL)
ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 04-JAN-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
MIDMARK CORP. 510(k) NO: K992744(TRADITIONAL)
ATTN: MIKE SNYDER PHONE NO : 937-526-8390
60 VISTA DR. SE DECISION MADE: 10-JAN-00
P.O. BOX 286 510(k) SUMMARY AVAILABLE FROM FDA
VERSAILLES, OH 45380
DEVICE: MILLENNIUM HUBER PLUS SAFETY INFUSION SET
MILLENNIUM MEDICAL DISTRIBUTION, I510(k) NO: K993848(TRADITIONAL)
ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312
1205 DE LA VINA SE DECISION MADE: 27-JAN-00
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0 ML RESERVOIR, MODEL 103/193
MINIMED TECHNOLOGIES, INC. 510(k) NO: K991936(TRADITIONAL)
ATTN: JENNIFER LYONS PHONE NO : 818-362-5958
12744 SAN FERNANDO RD. SE DECISION MADE: 18-JAN-00
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HENRY SCHEIN SURGICAL MASK
MITSUI TEXTILE CORP. 510(k) NO: K992604(TRADITIONAL)
ATTN: WILLIAM J BARONE PHONE NO : 212-827-1034
1450 BROADWAY 22ND FLOOR SE DECISION MADE: 28-JAN-00
NEW YORK, NY 10018 510(k) STATEMENT
DEVICE: TRX-CG POWER TILT AND RECLINE SYSTEM
MOTION CONCEPTS 510(k) NO: K994241(TRADITIONAL)
ATTN: ALLEN BOYD PHONE NO : 416 759 9937
101 BARTLEY DRIVE SE DECISION MADE: 13-JAN-00
TORONTO, ONTARIO, CANADA M4A 1C9 510(k) STATEMENT
DEVICE: MTP DISPOSABLE TROCARS
MTP MEDICAL TECHNICAL PROMOTION GM510(k) NO: K994066(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
P.O. BOX 1954 SE DECISION MADE: 20-JAN-00
CULVER CITY, CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANMA NON-ADJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K993906(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 31-JAN-00
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: NANMA AJUSTABLE CONSTRICTION RING
NANMA MFG CO., LTD. 510(k) NO: K993908(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 31-JAN-00
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: NEUROCOMP
NEUROCYBERNETICS 510(k) NO: K993654(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 27-JAN-00
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: MODEL 1000 HOLMIUM LASER SYSTEM
NEW STAR LASERS, INC. 510(k) NO: K994273(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 530-823-1434
11802 KEMPER RD. SE DECISION MADE: 20-JAN-00
AUBURN, CA 95603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PE 501 PC-ECG MONITOR
NHE CORPORATION 510(k) NO: K992584(TRADITIONAL)
ATTN: SHUGEN ZHANG PHONE NO : 804-755-1633
7100 FERNWOOD AVE SE DECISION MADE: 13-JAN-00
SUITE 1922 510(k) SUMMARY AVAILABLE FROM FDA
RICHMOND, VA 23228
DEVICE: NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K992455(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-250-3959
2601 CAMPUS DR. SE DECISION MADE: 07-JAN-00
IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO LUER ADAPTOR
NIPRO MEDICAL CORP. 510(k) NO: K992729(TRADITIONAL)
ATTN: KAELYN HADLEY PHONE NO : 606-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 13-JAN-00
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE
NOBEL BIOCARE USA, INC. 510(k) NO: K993595(TRADITIONAL)
ATTN: JEFF HAUSHEER PHONE NO : 714-282-4800
22725 SAVI RANCH PKWY. SE DECISION MADE: 28-JAN-00
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K993778(SPECIAL)
ATTN: CASEY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 06-JAN-00
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITP, MODEL 1.0
NUCLETRON CORP. 510(k) NO: K992434(TRADITIONAL)
ATTN: RALPH E SHUPING PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 13-JAN-00
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OHMEDA MEDICAL OMNIBED
OHMEDA MEDICAL 510(k) NO: K993407(TRADITIONAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-381-4004
9065 GUILFORD RD. SE DECISION MADE: 05-JAN-00
COLUMBIA, MD 21046-1801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
OLYMPUS DIAGNOSTICA GMBH 510(k) NO: K994189(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 20-JAN-00
MELVILLE, NY 11747 510(k) STATEMENT
DEVICE: OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYME
OMNIGRACE LTD. 510(k) NO: K994246(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878
7815 VANDERBILT DRIVE NW SE DECISION MADE: 31-JAN-00
NORTH CANTON, OH 44720 510(k) STATEMENT
DEVICE: ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
ORATEC INTERVENTIONS, INC. 510(k) NO: K994333(SPECIAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 18-JAN-00
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSI TITANIUM ANEURYSM CLIP
PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K991959(TRADITIONAL)
ATTN: TERRY JOHNSTON PHONE NO : 650-802-6988
360 INDUSTRIAL RD., UNIT H SE DECISION MADE: 06-JAN-00
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL HANDPIECE
PAULINE M. NICHOLLS 510(k) NO: K971732(TRADITIONAL)
ATTN: PAULINE M NICHOLLS PHONE NO : 770-267-7963
321 SOUTH BROAD STREET SE DECISION MADE: 11-JAN-00
MONROE, GA 30655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA TPO ANTIBODIES, MODEL 12348/12396
PHARMACIA & UPJOHN CO. 510(k) NO: K993585(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 05-JAN-00
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K993377(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO :
7736 ZIONSVILLE RD. SE DECISION MADE: 13-JAN-00
INDIANAPOLIS, IN 46268 510(k) STATEMENT
DEVICE: SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
PRECISION DYNAMICS CORP. 510(k) NO: K994263(TRADITIONAL)
ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111
13880 DEL SUR ST. SE DECISION MADE: 24-JAN-00
SAN FERNANDO, CA 91340-3490 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
PRIME DENTAL MANUFACTURING, INC. 510(k) NO: K994224(TRADITIONAL)
ATTN: ROLANDO MARASIGAN PHONE NO : 773-539-5927
3735 WEST BELMONT AVE. SE DECISION MADE: 31-JAN-00
CHICAGO, IL 60618 510(k) STATEMENT
DEVICE: UNSENTED INTERLABIAL MENSTRUAL PAD
PROCTER & GAMBLE CO. 510(k) NO: K993870(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6100 CENTER HILL AVE. SE DECISION MADE: 18-JAN-00
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATED CORE BIOPSY DEVICE
PROMEX, INC. 510(k) NO: K994272(TRADITIONAL)
ATTN: JOSEPH L MARK PHONE NO : 317-736-0128
3049 HUDSON STREET SE DECISION MADE: 07-JAN-00
FRANKLIN, IN 46131 510(k) STATEMENT
DEVICE: PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
PURE WATER, INC. 510(k) NO: K992786(TRADITIONAL)
ATTN: CYNTHIA P WALTERS PHONE NO : 864-375-0105
305 WEST MARKET STREET SE DECISION MADE: 24-JAN-00
ANDERSON, SC 29624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH
PURE WATER, INC. 510(k) NO: K993058(TRADITIONAL)
ATTN: RHONDA S MCCOY PHONE NO : 864-375-0105
305 WEST MARKET STREET SE DECISION MADE: 24-JAN-00
ANDERSON, SC 29624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
RADIOMETER AMERICA, INC. 510(k) NO: K992859(SPECIAL)
ATTN: VINCENT M SIGMUND PHONE NO : 440-871-8900
810 SHARON DR. SE DECISION MADE: 10-JAN-00
WESTLAKE, OH 44145-1598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAFREEZE
RHEALM PHARMACEUTICALS, INC. 510(k) NO: K992286(TRADITIONAL)
ATTN: RICHARD MANN PHONE NO : 561-736-1880
258 SE 6TH AVE., SUITE 12 SE DECISION MADE: 21-JAN-00
DELRAY BEACH, FL 33483 510(k) STATEMENT
DEVICE: RHIGENE ANA ELISA TEST SYSTEM
RHIGENE, INC 510(k) NO: K994071(TRADITIONAL)
ATTN: DAVE KOLESAR PHONE NO : 847-375-9091
455 STATE ST., SE DECISION MADE: 18-JAN-00
SUITE 104 510(k) STATEMENT
DES PLAINES, IL 60068
DEVICE: ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR CO
ROCHE DIAGNOSTICS CORP. 510(k) NO: K992851(TRADITIONAL)
ATTN: LUANN OCHS PHONE NO : 317-845-2000
9115 HAGUE RD. SE DECISION MADE: 14-JAN-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
ROCHE DIAGNOSTICS CORP. 510(k) NO: K994017(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE RD. SE DECISION MADE: 27-JAN-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
ROCHE DIAGNOSTICS CORP. 510(k) NO: K994020(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE RD. SE DECISION MADE: 27-JAN-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCUP 5, CAT. 07 6481 7
ROCHE DIAGNOSTICS CORP. 510(k) NO: K994030(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE RD. SE DECISION MADE: 27-JAN-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
ROSSMAX INTL. LTD. 510(k) NO: K993426(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 27835584
2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 07-JAN-00
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
ROSSMAX INTL. LTD. 510(k) NO: K993429(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 27835584
2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 07-JAN-00
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
ROSSMAX INTL. LTD. 510(k) NO: K993460(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 2783
2F. NO. 8, ALLEY 20 LANE 106 SE DECISION MADE: 11-JAN-00
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: MRP-TITAN
ROTEC MEDIZINTECHNIK GMBH 510(k) NO: K992403(TRADITIONAL)
ATTN: ING ULRICH HOLZWARTH PHONE NO : 499 135 3215
AM MUHLBERG 31 SE DECISION MADE: 21-JAN-00
WEISENDORF, GERMANY D-91084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
SAFESKIN CORP. 510(k) NO: K994081(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 858-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 18-JAN-00
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE F
SAGE BIOPHARMA 510(k) NO: K991390(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 18-JAN-00
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: SALTER AIRE COMPRESSOR
SALTER LABS 510(k) NO: K992285(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 805-854-3166
100 W. SYCAMORE ROAD SE DECISION MADE: 07-JAN-00
ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOSENSE, MODEL 29-8010
SDI DIAGNOSTICS, INC. 510(k) NO: K990962(TRADITIONAL)
ATTN: MICHAEL J BOYLE PHONE NO : 508-238-7033
10 HAMPDEN DR. SE DECISION MADE: 07-JAN-00
EASTON, MA 02375 510(k) STATEMENT
DEVICE: SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT
SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K993859(TRADITIONAL)
ATTN: MAO-SHENG LEE PHONE NO : 886 225 462479
NANKING E. RD., SEC 3 SE DECISION MADE: 12-JAN-00
TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT
SHANGHAI GLOVMAX ENTERPRISE CO.,LT510(k) NO: K993880(TRADITIONAL)
ATTN: MAO-SHENG LEE PHONE NO : 886 227 136677ET23
NANKING E. RD., SEC 3 SE DECISION MADE: 12-JAN-00
TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMI
SHINEMOUND ENTERPRISE, INC. 510(k) NO: K994248(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING RD. SE DECISION MADE: 28-JAN-00
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINA
SHINEMOUND ENTERPRISE, INC. 510(k) NO: K994258(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING RD. SE DECISION MADE: 20-JAN-00
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
SIEMENS MEDICAL CORP. 510(k) NO: K994316(SPECIAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4625
186 WOOD AVE. SO. SE DECISION MADE: 14-JAN-00
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMEMNS INFINITY ETC02 POD
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992116(TRADITIONAL)
ATTN: PENELOPE H GRECCO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 12-JAN-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA MANUAL WHEELCHAIR
SIGMA DISTRIBUTION & SUPPLY, INC. 510(k) NO: K993963(TRADITIONAL)
ATTN: ARTHUR KESHISHYAN PHONE NO : 818-246-4624
701 WEST HARVARD STREET SE DECISION MADE: 13-JAN-00
GLENDALE, CA 91204 510(k) STATEMENT
DEVICE: PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
SIMS DELTEC, INC. 510(k) NO: K994216(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 651-628-7224
1265 GREY FOX RD. SE DECISION MADE: 27-JAN-00
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPO
SIMS PORTEX, INC. 510(k) NO: K991861(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 18-JAN-00
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIORCI SCREW
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K992396(TRADITIONAL)
ATTN: DEMETRIOS TSAKONAS PHONE NO : 508-261-3775
130 FORBES BOULEVARD SE DECISION MADE: 12-JAN-00
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX ALUMINA CERAMIC FEMORAL HEAD
SMITH & NEPHEW, INC. 510(k) NO: K991162(ABBREVIATED)
ATTN: DAVID HENLEY PHONE NO : 901-396-2121
1450 E. BROOKS ROAD SE DECISION MADE: 28-JAN-00
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
SMITH & NEPHEW, INC. 510(k) NO: K994084(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
160 DASCOMB RD. SE DECISION MADE: 20-JAN-00
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
SPACELABS MEDICAL, INC. 510(k) NO: K992749(TRADITIONAL)
ATTN: NANCY GERTLAR PHONE NO : 425-867-7315
15220 NORTH EAST 40TH ST. SE DECISION MADE: 14-JAN-00
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAUTERY GRASPER/DISSECTOR
STARION INSTRUMENTS 510(k) NO: K994019(TRADITIONAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 20-JAN-00
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTEC
STELLARTECH RESEARCH CORP. 510(k) NO: K994173(ABBREVIATED)
ATTN: JAMES R SANTOS PHONE NO : 408-331-3000
1346 BORDEAUX DR. SE DECISION MADE: 20-JAN-00
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XE CHECK
STRECK LABORATORIES, INC. 510(k) NO: K994388(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-691-7465
14124 INDUSTRIAL RD. SE DECISION MADE: 14-JAN-00
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
STRYKER CORP. 510(k) NO: K993239(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVENUE SE DECISION MADE: 18-JAN-00
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
SULZER MEDICA 510(k) NO: K993667(TRADITIONAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-435-3407
1300 EAST ANDERSON LANE SE DECISION MADE: 28-JAN-00
AUSTIN, TX 78752-1793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
SUPERMAX SDN BHD 510(k) NO: K993864(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 657 2328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 20-JAN-00
BUKIT RAHMAN PUTRA 510(k) STATEMENT
47000 SUNGAI BULOH SELANGOR, MALAYSIA
DEVICE: GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
SUPERMAX SDN BHD 510(k) NO: K993865(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 657 2328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 20-JAN-00
BUKIT RAHMAN PUTRA 510(k) STATEMENT
47000 SUNGAI BULOH SELANGOR, MALAYSIA
DEVICE: RIM-FIX, ACETABULAR CUP
SURGICAL IMPLANTS, INC. 510(k) NO: K993713(TRADITIONAL)
ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL, #203 SE DECISION MADE: 28-JAN-00
SARASOTA, FL 34326 510(k) STATEMENT
DEVICE: PHARMASEED, MODEL BT-103-1
SYNCOR PHARMACEUTICALS, INC. 510(k) NO: K992007(TRADITIONAL)
ATTN: GARY GILMORE PHONE NO : 303-279-1014
1313 WASHINGTON AVENUE SE DECISION MADE: 14-JAN-00
GOLDEN, CO 80401 510(k) STATEMENT
DEVICE: ABBOTT AEROSET PHENYTOIN ASSAY AND CALIBRATORS; MODELS 1E07 AND
SYVA CO. 510(k) NO: K993026(TRADITIONAL)
ATTN: PAUL L ROGERS JR. PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12
SYVA CO. 510(k) NO: K993028(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 A
SYVA CO. 510(k) NO: K993029(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 A
SYVA CO. 510(k) NO: K993031(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C12
SYVA CO. 510(k) NO: K993982(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
SYVA CO. 510(k) NO: K993983(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
SYVA CO. 510(k) NO: K993984(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 18-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
SYVA CO. 510(k) NO: K993985(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
SYVA CO. 510(k) NO: K993986(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
SYVA CO. 510(k) NO: K993987(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
SYVA CO. 510(k) NO: K993988(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 27-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
SYVA CO. 510(k) NO: K994005(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
3403 YERBA BUENA RD. SE DECISION MADE: 20-JAN-00
P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013
DEVICE: GOWN BACK, MODEL 13-403N; 13-404N; 13-405N
TECHSTYLES, INC. 510(k) NO: K992436(TRADITIONAL)
ATTN: STEPHANIE T HOWARD PHONE NO : 972-732-7694
16415 ADDISON RD., SUITE 850 SE DECISION MADE: 20-JAN-00
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND
TECO DIAGNOSTICS 510(k) NO: K000067(SPECIAL)
ATTN: DINDO CARRILLO PHONE NO : 714-693-7788
4925 EAST HUNTER AVE. SE DECISION MADE: 20-JAN-00
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: TFX MEDICAL INTRODUCER KIT
TFX MEDICAL GROUP 510(k) NO: K991647(TRADITIONAL)
ATTN: JULIE A BEAUMONT PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 04-JAN-00
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX CONDOM
THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K994095(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-7040
1219 LITTLE CREEK RD. SE DECISION MADE: 18-JAN-00
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERLIX MD ANTIMICROBIAL GAUZE DRESSING
THE KENDALL COMPANY, L.P. 510(k) NO: K990530(TRADITIONAL)
ATTN: DAVID A OLSON PHONE NO : 508-261-8530
15 HAMPSHIRE ST. SE DECISION MADE: 31-JAN-00
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
THERASENSE, INC. 510(k) NO: K992684(TRADITIONAL)
ATTN: EVE A CONNER PHONE NO : 510-749-5400
1360 SOUTH LOOP DRIVE SE DECISION MADE: 14-JAN-00
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
TOP GLOVE SDN. BHD. 510(k) NO: K993664(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 19921905
LOT 4968 JALAN TERATAI, BATU 6 SE DECISION MADE: 11-JAN-00
OFFJALAN MERU, 41050 KLANG 510(k) STATEMENT
SELANGOR, D.E., MALAYSIA
DEVICE: OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
TOSHIBA AMERICA MRI, INC. 510(k) NO: K993574(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 18-JAN-00
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENA PROFILE ELISA TEST SYSTEM
TRINITY BIOTECH USA 510(k) NO: K993839(TRADITIONAL)
ATTN: WAYNE KVETKOSKY PHONE NO : 716-483-3851
2823 GIRTS RD. SE DECISION MADE: 12-JAN-00
JAMESTOWN, NY 14702 510(k) STATEMENT
DEVICE: UNIGRAFT
UNICARE BIOMEDICAL 510(k) NO: K993784()
ATTN: STAN YANG PHONE NO : 949-362-1772
25951 LA CUESTA AVENUE SE DECISION MADE: 27-JAN-00
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHASED ARRAY KNEE AND FOOT COIL
USA INSTRUMENTS, INC. 510(k) NO: K994040(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 18-JAN-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARP 9000 PHASED ARRAY BRAIN COIL
USA INSTRUMENTS, INC. 510(k) NO: K994042(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 31-JAN-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE BILIARY CATHETER
VASCUTECH, INC. 510(k) NO: K992941(TRADITIONAL)
ATTN: TRENT G KAMKE PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE SE DECISION MADE: 12-JAN-00
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTI
VIDAR SYSTEMS CORP. 510(k) NO: K993598(TRADITIONAL)
ATTN: MARY "PENNIE" DRINKARD PHONE NO : 703-471-7070
460 SPRING PARK PL. SE DECISION MADE: 20-JAN-00
HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMET
VIDAR SYSTEMS CORP. 510(k) NO: K993599(TRADITIONAL)
ATTN: MARY "PENNIE" DRINKARD PHONE NO : 703-471-7070
460 SPRING PARK PL. SE DECISION MADE: 18-JAN-00
HERNDON, VA 20170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYS
VIRGINIA WATER SYSTEMS, INC. 510(k) NO: K991916(TRADITIONAL)
ATTN: WILLIAM G GARRAHAN PHONE NO : 804-743-0034
7433 WHITEPINE RD. SE DECISION MADE: 14-JAN-00
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UFI GEL HARD
VOCO GMBH 510(k) NO: K993827(TRADITIONAL)
ATTN: SHUOJIA DONG PHONE NO : 450 646 1330
4235 BEACONSFIELD SE DECISION MADE: 20-JAN-00
MONTREAL, CANADA QC,H4A 2H4 510(k) STATEMENT
DEVICE: ADMIRA
VOCO GMBH 510(k) NO: K994056(TRADITIONAL)
ATTN: EVAN DICK PHONE NO : 314-721-0112
7527 WESTMORELAND AVE. SE DECISION MADE: 12-JAN-00
ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STA
WAKO CHEMICALS, USA, INC. 510(k) NO: K993924(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 14-JAN-00
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN ST
WAKO CHEMICALS, USA, INC. 510(k) NO: K993927(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 14-JAN-00
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STA
WAKO CHEMICALS, USA, INC. 510(k) NO: K993928(TRADITIONAL)
ATTN: TANYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 18-JAN-00
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992675(TRADITIONAL)
ATTN: CLAUDE COTTET PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 20-JAN-00
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: OSOM ULTRA STREP A TEST, MODEL 147
WYNTEK DIAGNOSTICS, INC. 510(k) NO: K992658(TRADITIONAL)
ATTN: SHU-CHING CHENG PHONE NO : 858-452-3198
6146 NANCY RIDGE DR., SE DECISION MADE: 18-JAN-00
SUITE 101 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWER
XOMED, INC. 510(k) NO: K992855(TRADITIONAL)
ATTN: DAVID TIMLIN PHONE NO : 904-279-7532
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 21-JAN-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LASER-SHIELD II
XOMED, INC. 510(k) NO: K993582(TRADITIONAL)
ATTN: ROY BERENS PHONE NO : 904-296-6454
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 20-JAN-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 283
TOTAL WITH SUMMARIES 200
TOTAL WITH STATEMENTS 83
Updated 3/20/2000
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