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Medical Devices
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February 2000 510(k) Clearances
DEVICE: GENX CULTURE DISH GENX INTL., INC. 510(k) NO: K993881(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD. SE DECISION MADE: 14-FEB-00 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENX MICROTOOLS GENX INTL., INC. 510(k) NO: K993884(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD. SE DECISION MADE: 14-FEB-00 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 A & A MEDICAL, INC. 510(k) NO: K994256(TRADITIONAL) ATTN: JIHAD MANSOUR PHONE NO : 770-343-8400 9370 INDUSTRIAL TRACE SE DECISION MADE: 03-FEB-00 ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ACCELERATED REHAB DESIGNS, INC. 510(k) NO: K992804(TRADITIONAL) ATTN: RANDALL POTTER PHONE NO : 281-356-1950 32025 INDUSTRIAL PARK DR. SE DECISION MADE: 03-FEB-00 PINEHURST, TX 77362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320 ACCELERATED REHAB DESIGNS, INC. 510(k) NO: K992828(TRADITIONAL) ATTN: RANDALL POTTER PHONE NO : 281-356-1950 32025 INDUSTRIAL PARK DR. SE DECISION MADE: 03-FEB-00 PINEHURST, TX 77362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED MODULAR SHOULDER SYSTEM ACUMED, INC. 510(k) NO: K992525(TRADITIONAL) ATTN: SHARI JEFFERS PHONE NO : 503-627-9957 10950 S.W. 5TH ST., SUITE 170 SE DECISION MADE: 04-FEB-00 BEAVERTON, OR 97005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EX ADVANCED BIOMEDICAL DEVICES, INC. 510(k) NO: K981936(TRADITIONAL) ATTN: R. EDWARD WINTERS PHONE NO : 978-470-1177 3 DUNDEE PARK SE DECISION MADE: 16-FEB-00 ANDOVER, MA 01810 510(k) STATEMENT DEVICE: VERIPATH PERIPHERAL GUIDING CATHETER ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K994229(SPECIAL) ATTN: STACEY SIMON PHONE NO : 909-914-4527 26531 YNEZ RD. SE DECISION MADE: 25-FEB-00 TEMECULA, CA 92591-4628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUINN'S SPERM WASHING MEDIUM ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991379(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVENUE SAUSALITO SE DECISION MADE: 02-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: HUMAN SERUM ALBUMIN ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991392(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVENUE SAUSALITO SE DECISION MADE: 07-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991395(TRADITIONAL) ATTN: GRER HOLLAND PHONE NO : 949-262-0411 3722 AVENUE SAUSALITO SE DECISION MADE: 15-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: WILTSE SYSTEM ADVANCED SPINE FIXATION SYSTEMS, I510(k) NO: K992012(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 04-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: TRIPLE-FIX SPINAL FIXATION SYSTEM ADVANCED SPINE TECHNOLOGY, INC. 510(k) NO: K992147(TRADITIONAL) ATTN: GORDON TAO PHONE NO : 510-251-6798 3645GRAND AVE., SUITE 304 SE DECISION MADE: 28-FEB-00 OAKLAND, CA 94610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE HCG TEST (URINE/SERUM) ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K994227(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 2440 LEGHORN ST. SE DECISION MADE: 03-FEB-00 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO AGFA CORP. 510(k) NO: K000159(SPECIAL) ATTN: TIMOTHY W CAPEHART PHONE NO : 864-421-1834 10 SOUTH ACADEMY ST. SE DECISION MADE: 16-FEB-00 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K994162(SPECIAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN ROAD BUILDING K SE DECISION MADE: 09-FEB-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS SURGICAL GOWNS, STERILE ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K994244(TRADITIONAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 18-FEB-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 10 CURIE IRDIUM 192, CSN00100-192 ALPHA-OMEGA SERVICES, INC. 510(k) NO: K991571(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 22-FEB-00 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R1000 SERIES INSULIN PUMP ANIMAS CORPORATION 510(k) NO: K993184(TRADITIONAL) ATTN: MONICA FERRANTE PHONE NO : 610-644-8990 590 E. LANCASTER AVENUE SE DECISION MADE: 10-FEB-00 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN ANSELL PERRY INC. 510(k) NO: K000295(SPECIAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 16-FEB-00 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER ARROW INTL., INC. 510(k) NO: K993966(SPECIAL) ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400 9 PLYMOUTH ST. SE DECISION MADE: 18-FEB-00 EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTEC REFLEX WAND 55, MODEL E4055-00 ARTHROCARE CORP. 510(k) NO: K000036(TRADITIONAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-1224 595 NORTH PASTORIA AVE. SE DECISION MADE: 04-FEB-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE CORP. 510(k) NO: K000044(SPECIAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 01-FEB-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE CORP. 510(k) NO: K000074(SPECIAL) ATTN: BETTY M JOHNSON PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 04-FEB-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PL ARTHROCARE CORP. 510(k) NO: K000228(SPECIAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 22-FEB-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO AVOCET MEDICAL, INC. 510(k) NO: K994006(TRADITIONAL) ATTN: JILL FALCONE PHONE NO : 408-574-6638 100 GREAT OAKS BLVD. SE DECISION MADE: 03-FEB-00 SAN JOSE, CA 95119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCOMED 2MP2 BARCO NV 510(k) NO: K000015(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 04-FEB-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP. 510(k) NO: K992662(TRADITIONAL) ATTN: GABRIEL J MURACA PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 15-FEB-00 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 3331 BECKMAN COULTER, INC. 510(k) NO: K000196(TRADITIONAL) ATTN: JAN OLSEN PHONE NO : 612-368-7688 1000 LAKE HAZELTINE DR. SE DECISION MADE: 18-FEB-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K000331(TRADITIONAL) ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 10-FEB-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION BECKMAN COULTER, INC. 510(k) NO: K993547(TRADITIONAL) ATTN: RICHARD T ROSS PHONE NO : 714-961-4912 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 01-FEB-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION BECKMAN COULTER, INC. 510(k) NO: K993549(TRADITIONAL) ATTN: RICHARD T ROSS PHONE NO : 714-961-4912 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 01-FEB-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K994168(TRADITIONAL) ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 03-FEB-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR BECKMAN COULTER, INC. 510(k) NO: K994169(TRADITIONAL) ATTN: LUCINDA STOCKERT PHONE NO : 714-961-3777 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 03-FEB-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-N BIO-VASCULAR, INC. 510(k) NO: K992537(TRADITIONAL) ATTN: MARY KAY KESSINGER SOBCINSKPHONE NO : 651-603-3703 2575 UNIVERSITY AVE., STE.180 SE DECISION MADE: 22-FEB-00 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS BIOCELL LABORATORIES, INC. 510(k) NO: K000056(TRADITIONAL) ATTN: MARC M MCKONIC PHONE NO : 310-537-3300 2001 UNIVERSITY DR. SE DECISION MADE: 24-FEB-00 RANCHO DOMINGUEZ, CA 90220-6411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOGRAPH STAPLE, WARM SYSTEM BIOMEDICAL ENT., INC. 510(k) NO: K993714(TRADITIONAL) ATTN: W. CASEY FOX PHONE NO : 210-677-0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 25-FEB-00 SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAR 5 ACETABULAR COMPONENT BIOMET, INC. 510(k) NO: K000254(SPECIAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 07-FEB-00 WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPACT MODULAR TOTAL HIP SYSTEM BIOMET, INC. 510(k) NO: K000334(SPECIAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 16-FEB-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM BIOMET, INC. 510(k) NO: K000335(SPECIAL) ATTN: FRED MCCLURE PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 25-FEB-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: DISPOSABLE INFUSION PUMP KIT BIOMET, INC. 510(k) NO: K993972(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 07-FEB-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: MALLORY/HEAD SMOOTH FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K994007(TRADITIONAL) ATTN: TINA LAKIN PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 04-FEB-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: PLR SPLINED REVISION STEM BIOMET, INC. 510(k) NO: K994184(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 15-FEB-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FAS BIONOSTICS INC. 510(k) NO: K000318(TRADITIONAL) ATTN: KATHLEEN STORRO PHONE NO : 978-263-3856 2 CRAIG RD. SE DECISION MADE: 28-FEB-00 ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7250 (MEGAS) BIOSOUND ESAOTE, INC. 510(k) NO: K994369(TRADITIONAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793 8000 CASTLEWAY DR. SE DECISION MADE: 24-FEB-00 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTEQUE HEMODIALYSIS BLOOD TUBING SET BIOTEQUE CORP. 510(k) NO: K992930(TRADITIONAL) ATTN: ALLEN REICH PHONE NO : 520-773-9488 900 N. SWITZER CANYON DR. #142 SE DECISION MADE: 09-FEB-00 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONTOPATCH BIRCH POINT MEDICAL, INC. 510(k) NO: K992708(TRADITIONAL) ATTN: WALTER L SEMBROWICH PHONE NO : 651-628-0737 2660 PATTON ROAD SE DECISION MADE: 01-FEB-00 ROSEVILLE, MN 55113 510(k) STATEMENT DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K994217(TRADITIONAL) ATTN: ALAN LOMBARDO PHONE NO : 888-298-5400 90 BROOKSDALE DR. SE DECISION MADE: 28-FEB-00 SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. 510(k) NO: K000409(SPECIAL) ATTN: JOCELYN KERSTEN PHONE NO : 425-556-1667 17425 NORTH EAST UNION HILL RD SE DECISION MADE: 28-FEB-00 NORTHWEST TECHNOLOGY CENTER 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052-3376 DEVICE: ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE CALIFORNIA MEDICAL LABORATORIES, I510(k) NO: K993818(TRADITIONAL) ATTN: MEHMET BICAKCI PHONE NO : 949-553-9414 2681 KELVIN AVENUE SE DECISION MADE: 08-FEB-00 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K000225(SPECIAL) ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600 2 PEKERIS ST., SCIENCE PARK SE DECISION MADE: 11-FEB-00 P.O.B. 527 510(k) STATEMENT REHOVOT, ISRAEL 76100 DEVICE: SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C CARDIOFOCUS INC. 510(k) NO: K993834(TRADITIONAL) ATTN: WILLIAM A KNAPE PHONE NO : 408-399-9347 987 UNIVERSITY AVENUE SE DECISION MADE: 04-FEB-00 SUITE 14 510(k) SUMMARY AVAILABLE FROM FDA LOS GATOS, CA 95032 DEVICE: HMP CONTROLS (TAS) RAPIDPOINT CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K994159(TRADITIONAL) ATTN: PETER SCOTT PHONE NO : 800-247-4234 5301 DEPARTURE DR. SE DECISION MADE: 15-FEB-00 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PR3 ULTRASOUND SYSTEM CAROLINA MEDICAL, INC. 510(k) NO: K993978(TRADITIONAL) ATTN: CARROLL L TURNER PHONE NO : 336-983-5132 157 INDUSTRIAL DR. SE DECISION MADE: 10-FEB-00 KING, NC 27021 510(k) STATEMENT DEVICE: SYNTHETIC VDRL ANTIGEN CENTERS FOR DISEASE CONTROL 510(k) NO: K993633(TRADITIONAL) ATTN: VICTORIA POPE PHONE NO : 404-639-3224 1600 CLIFTON RD., N.E. SE DECISION MADE: 23-FEB-00 ATLANTA, GA 30333 510(k) STATEMENT DEVICE: CERALAS D10 810NM DIODE LASER CERAMOPTEC, INC. 510(k) NO: K993828(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 01-FEB-00 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 CERAMOPTEC, INC. 510(k) NO: K993911(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 01-FEB-00 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPOT ENDOSCOPIC MARKER CHEK-MED SYSTEMS 510(k) NO: K993951(TRADITIONAL) ATTN: ROB WHALEN PHONE NO : 860-429-9221 11 PHELPS WAY SE DECISION MADE: 18-FEB-00 P.O. BOX 289 510(k) STATEMENT WILLINGTON, CT 06279 DEVICE: COALESCENT SURGICAL SUTURED-CLIP COALESCENT SURGICAL 510(k) NO: K994160(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223 559 EAST WEDDELL DR. SE DECISION MADE: 04-FEB-00 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K993085(TRADITIONAL) ATTN: RANDY WILSON PHONE NO : 714-933-3000 7272 CHAPMAN AVENUE SE DECISION MADE: 01-FEB-00 GARDEN GROVE, CA 92841 510(k) STATEMENT DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGM ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K994338(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 03-FEB-00 BUSH LOAN, PENICUIK 510(k) STATEMENT MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL DEVICE: QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 CONSOLIDATED TECHNOLOGIES INC. 510(k) NO: K000116(TRADITIONAL) ATTN: RUSTY SEWELL PHONE NO : 512-445-5100 2170 WOODWARD, NO. 100 SE DECISION MADE: 15-FEB-00 AUSTIN, TX 78744 510(k) STATEMENT DEVICE: SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 CONWAY STUART MEDICAL, INC. 510(k) NO: K000170(SPECIAL) ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 14-FEB-00 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS CORIN U.S.A. 510(k) NO: K000232(SPECIAL) ATTN: CRAIG CORRANCE PHONE NO : 813-977-4469 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 25-FEB-00 SUITE 190 510(k) STATEMENT TAMPA, FL 33612 DEVICE: CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS CORIN U.S.A. 510(k) NO: K994153(TRADITIONAL) ATTN: CRAIG CORRANCE PHONE NO : 813-979-0042 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 25-FEB-00 SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA TAMPA, FL 33612 DEVICE: DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 CRITIKON COMPANY,LLC 510(k) NO: K992638(TRADITIONAL) ATTN: THOMAS ENGLISH PHONE NO : 813-887-2107 4110 GEORGE RD. SE DECISION MADE: 24-FEB-00 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION TRNF FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K994294(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6537 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 04-FEB-00 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: MICROSTREP PLUS PANEL, LEVOFLOXACIN DADE MICROSCAN, INC. 510(k) NO: K983943(TRADITIONAL) ATTN: SHAROLYN J LENTSCH PHONE NO : 916-374-8183 1584 ENTERPRISE BLVD. SE DECISION MADE: 18-FEB-00 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NASOGASTRIC TUBE HOLDER, MODEL 160 DALE MEDICAL PRODUCTS, INC. 510(k) NO: K994300(TRADITIONAL) ATTN: JOHN C BREZACK PHONE NO : 800-343-3980 7 CROSS ST., P.O. BOX 1556 SE DECISION MADE: 10-FEB-00 PLAINVILLE, MA 02762 510(k) STATEMENT DEVICE: CD HORIZON SPINAL SYSTEM DANEK MEDICAL, INC. 510(k) NO: K993810(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 03-FEB-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE GRAFT WASHER, MODEL 9090114 - 9090118 DANEK MEDICAL, INC. 510(k) NO: K994122(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 18-FEB-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA INOVENT DELIVERY SYSTEM DATEX-OHMEDA 510(k) NO: K000186(SPECIAL) ATTN: DANIEL KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 10-FEB-00 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM DBA SYSTEMS INC. 510(k) NO: K992467(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 13TH STREET, N.W. SE DECISION MADE: 10-FEB-00 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFINITE DEGUSSA - NEY DENTAL, INC. 510(k) NO: K993514(TRADITIONAL) ATTN: THOMAS B CAMERON PHONE NO : 800-243-1942 65 WEST DUDLY TOWN RD. SE DECISION MADE: 24-FEB-00 BLOOMFIELD, CT 06002 510(k) STATEMENT DEVICE: ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, DENTSPLY INTL. 510(k) NO: K994211(TRADITIONAL) ATTN: WILLIAM T COUSINS PHONE NO : 847-640-4924 901 WEST OAKTON ST. SE DECISION MADE: 04-FEB-00 DES PLAINES, IL 60018-1884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K000172(SPECIAL) ATTN: CHERYL HASTINGS PHONE NO : 219-371-4940 700 ORTHOPAEDIC DR. SE DECISION MADE: 03-FEB-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POROCOAT PRODIGY HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K000207(SPECIAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 04-FEB-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K994415(SPECIAL) ATTN: CHERYL HASTINGS PHONE NO : 219-371-4901 700 ORTHOPAEDIC DR. SE DECISION MADE: 03-FEB-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPOFIT, MODEL 02693 DETAX GMBH & CO. KG 510(k) NO: K994012(TRADITIONAL) ATTN: BARRY HALE PHONE NO : 816-322-4641 7707 E. 201 TERR SE DECISION MADE: 16-FEB-00 BELTON, MO 64012 510(k) STATEMENT DEVICE: IMMUNOCYT DIAGNOCURE, INC. 510(k) NO: K994356(TRADITIONAL) ATTN: BRUCE F MACKLER PHONE NO : 202-785-4747 815 CONNECTICUT AVE, N.W. SE DECISION MADE: 23-FEB-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006-4004 DEVICE: CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K000055(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 18-FEB-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K994035(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 01-FEB-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YEASTEST DIAGNOSTIC MARKERS, INC. 510(k) NO: K993554(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 10-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LK DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K000006(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 28-FEB-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # L DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K000007(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 28-FEB-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K000257(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 23-FEB-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K994424(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 18-FEB-00 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPALIS RUBELLA IGM DIASORIN INC. 510(k) NO: K993291(TRADITIONAL) ATTN: JUDITH J SMITH PHONE NO : 301-497-0005 9175 GUILFORD RD., SUITE 100 SE DECISION MADE: 10-FEB-00 QUARRY PARK PLACE 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21046 DEVICE: LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O DIDECO S.P.A. 510(k) NO: K991737(TRADITIONAL) ATTN: BARRY SALL PHONE NO : 781-684-9201 1601 TRAPELO ROAD SE DECISION MADE: 17-FEB-00 WALTHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUGUARD DIGIT-PRO 510(k) NO: K992539(TRADITIONAL) ATTN: KEVIN SORRELS PHONE NO : 713-983-7778 10555 WEST LITTLE YORK ROAD SE DECISION MADE: 18-FEB-00 HOUSTON, TX 77041 510(k) STATEMENT DEVICE: T-GEAR, MODEL TG/400-700 DONTECH PRODUCTS B.V. 510(k) NO: K993224(TRADITIONAL) ATTN: JAN JORENS PHONE NO : 003 118 3660055 AVELINGENWEST 27C SE DECISION MADE: 11-FEB-00 GORINCHEM, ZH, NETHERLANDS 510(k) STATEMENT DEVICE: X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 DYNARAD CORP. 510(k) NO: K000052(TRADITIONAL) ATTN: RAYMONF MANEZ PHONE NO : 516-242-5550 19 JEFRYN BLVD. WEST SE DECISION MADE: 10-FEB-00 DEER PARK, NY 11729 510(k) STATEMENT DEVICE: KODAK HOME HEALTH MONITORING SYSTEM EASTMAN KODAK CO. 510(k) NO: K983928(TRADITIONAL) ATTN: JUDITH A WALLACE PHONE NO : 716-726-6763 901 ELMGROVE RD. SE DECISION MADE: 11-FEB-00 ROCHESTER, NY 14653-4757 510(k) STATEMENT DEVICE: EBI XFIX DFS RAIL SYSTEM EBI, L.P. 510(k) NO: K000083(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 03-FEB-00 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DFS SYSTEM EBI, L.P. 510(k) NO: K000319(SPECIAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 25-FEB-00 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K000020(SPECIAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 03-FEB-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROU ENCORE ORTHOPEDICS, INC. 510(k) NO: K993943(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 04-FEB-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM ENDIUS INC. 510(k) NO: K994425(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 16-FEB-00 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYCON PRO ERICH JAEGER B.V. 510(k) NO: K992214(TRADITIONAL) ATTN: LEO DEN BAKKER PHONE NO : 313 065 94600 REGULIERENRING 11 SE DECISION MADE: 22-FEB-00 BUNNIK, NETHERLANDS 3981 LA 510(k) STATEMENT DEVICE: ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT ESC MEDICAL SYSTEMS LTD. 510(k) NO: K994014(TRADITIONAL) ATTN: ZVI LADIN PHONE NO : 781-444-8446 250 FIRST AVENUE SE DECISION MADE: 24-FEB-00 NEEDHAM, MA 02194 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNECARE LAPAROSCOPIC MORCELLATOR ETHICON, INC. 510(k) NO: K993801(TRADITIONAL) ATTN: GREGORY R JONES PHONE NO : 908-218-2481 ROUTE 22, WEST SE DECISION MADE: 07-FEB-00 P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876-0151 DEVICE: REMOTEIMAGE SYSTEM ETRAUMA, LLC 510(k) NO: K994228(TRADITIONAL) ATTN: DAN HODGEMAN PHONE NO : 954-421-5623 1425 EAST NEWPORT CENTER DRIVE SE DECISION MADE: 22-FEB-00 DEERFIELD BEACH, FL 33442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BITX PROBES EVEREST MEDICAL CORP. 510(k) NO: K994336(TRADITIONAL) ATTN: FREDERICK G MADES PHONE NO : 612-473-6262 13755 FIRST AVE. NORTH, #500 SE DECISION MADE: 08-FEB-00 MINNEAPOLIS, MN 55441-5454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-S EXACTECH, INC. 510(k) NO: K000242(SPECIAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 16-FEB-00 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXEL INJECTION PLUG WITH CAP EXEL INTL. 510(k) NO: K992290(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 P.O. BOX 3194 SE DECISION MADE: 23-FEB-00 CULVER CITY, CA 90231-3194 510(k) STATEMENT DEVICE: EXEL I.V. BLOOD LINE SET EXELINT INTL. CO. 510(k) NO: K992039(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 WEST CENTINELA AVE. SE DECISION MADE: 10-FEB-00 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE FLEXITECH SDN. BHD. 510(k) NO: K994416(TRADITIONAL) ATTN: Y. F HEW PHONE NO : 603 392 0188 LOT 5071, BATU 5 1/2, JALAN SE DECISION MADE: 03-FEB-00 MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: INSTACHECK MULTI-DRUG BAR/BZO TEST, MODEL 205C; INSTACHECK MULTI FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K994414(ABBREVIATED) ATTN: FENG-YU LEE PHONE NO : 949-595-0673 23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 17-FEB-00 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIOS MICROSAW FRIADENT GMBH 510(k) NO: K994298(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 18-FEB-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FUJI MEDICAL SYSTEMS U.S.A., INC. 510(k) NO: K993861(TRADITIONAL) ATTN: JOSEPH M AZARY PHONE NO : 203-602-3677 419 WEST AVE. SE DECISION MADE: 10-FEB-00 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GASTRO-INTESTINAL SYSTEM EN-410WM FUJINON, INC. 510(k) NO: K993704(TRADITIONAL) ATTN: GARY ADLER PHONE NO : 212-318-7700 399 PARK AVENUE SE DECISION MADE: 11-FEB-00 NEW YORK, NY 10022-4689 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYO-HIT GALIL MEDICAL LTD. 510(k) NO: K993965(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN ST. SE DECISION MADE: 18-FEB-00 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COROMETRICS MODEL 173 FETAL MONITOR GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K993751(TRADITIONAL) ATTN: RICHARD CEHOVSKY PHONE NO : 203-949-8320 61 BARNES PARK RD., NORTH SE DECISION MADE: 02-FEB-00 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSPEED 2.0CT SCANNER SYSTEM GE MEDICAL SYSTEMS, INC. 510(k) NO: K000300(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 15-FEB-00 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LCV+ VERSION 2 GE MEDICAL SYSTEMS, INC. 510(k) NO: K993037(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 14-FEB-00 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE GENESIS INDUSTRIES, INC. 510(k) NO: K994361(TRADITIONAL) ATTN: ANGELA RICHARDSON PHONE NO : 715-778-5821 303 S. MCKAY AVENUE SE DECISION MADE: 18-FEB-00 P.O. BOX 39 510(k) SUMMARY AVAILABLE FROM FDA SPRING VALLEY, WI 54767 DEVICE: GTI-FVIII INHIBITOR ASSAY GENETIC TESTING INSTITUTE 510(k) NO: K993553(TRADITIONAL) ATTN: MICHAEL MOGHADDAM PHONE NO : 414-792-3900 150 NORTH PATRICK BLVD. SE DECISION MADE: 01-FEB-00 BROOKFIELD, WI 53045-5837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASTLE SERIES 100HC STEAM STERILIZERS GETINGE/CASTLE, INC. 510(k) NO: K994314(SPECIAL) ATTN: MARK N SMITH PHONE NO : 716-272-5013 1777 EAST HENRIETTA RD. SE DECISION MADE: 16-FEB-00 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, GRADIPORE LTD. 510(k) NO: K993332(TRADITIONAL) ATTN: RHONDA PILGRIM PHONE NO : 011 612 98251514 LOT16 RIVERSIDE CORPORATE PARK SE DECISION MADE: 16-FEB-00 35-105 DELHI ROAD 510(k) SUMMARY AVAILABLE FROM FDA NORTH RYDE, AUSTRALIA NSW 2113 DEVICE: RX VIATRAC 14 PERIPHERAL DILATATION CATHETER GUIDANT CORP. 510(k) NO: K000101(SPECIAL) ATTN: KOBBY DANKWAH PHONE NO : 408-845-3127 3200 LAKESIDE DR. SE DECISION MADE: 10-FEB-00 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K000090(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 10-FEB-00 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: HARDYDISK CEFAMANDOLE, 30MCG HARDY DIAGNOSTICS 510(k) NO: K000022(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 17-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, CEFAZOLIN, 30MCG HARDY DIAGNOSTICS 510(k) NO: K000128(TRADITIONAL) ATTN: MELISSA TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 18-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, PIPERACILLIN, 100MCG HARDY DIAGNOSTICS 510(k) NO: K000183(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 28-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFACLOR 30MCG HARDY DIAGNOSTICS 510(k) NO: K994046(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 01-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CHLORAMPHENICOL, 30MCG HARDY DIAGNOSTICS 510(k) NO: K994089(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 11-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK GENTAMICIN, 10MCG HARDY DIAGNOSTICS 510(k) NO: K994091(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 11-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFIXIME, 5MCG HARDY DIAGNOSTICS 510(k) NO: K994129(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 11-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK OXACILLIN, 1MCG HARDY DIAGNOSTICS 510(k) NO: K994134(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 17-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK ERYTHROMYCIN, 15MCG HARDY DIAGNOSTICS 510(k) NO: K994135(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 16-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK NORFLOXACIN, 10MCG HARDY DIAGNOSTICS 510(k) NO: K994150(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 16-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK MEZLOCILLIN 75MCG HARDY DIAGNOSTICS 510(k) NO: K994212(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 15-FEB-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MON HEWLETT-PACKARD GMBH 510(k) NO: K993383(ABBREVIATED) ATTN: EGON PFEIL PHONE NO : 703-114-2243 HERRENBERGER STR. 110-140 SE DECISION MADE: 03-FEB-00 BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSALET 7700 CARE CENTER, MODEL # 7700 HILL-ROM AIR-SHIELDS 510(k) NO: K993051(TRADITIONAL) ATTN: JAMES G CARPENTER PHONE NO : 215-675-5200 330 JACKSONVILLE RD. SE DECISION MADE: 03-FEB-00 HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYST HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K994196(TRADITIONAL) ATTN: JOHN TARTAL PHONE NO : 706-846-3126 1 HORIZON WAY SE DECISION MADE: 10-FEB-00 MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORTMANN ECHOMASTER OAE ANALYZER HORTMANN AG 510(k) NO: K994033(TRADITIONAL) ATTN: BRADFORD MELANCON PHONE NO : 512-858-1781 P.O. BOX 1119 SE DECISION MADE: 24-FEB-00 DRIPPING SPRINGS, TX 78620-1119 510(k) STATEMENT DEVICE: EXETER CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP. 510(k) NO: K993889(TRADITIONAL) ATTN: NANCY J RIEDER PHONE NO : 201-507-7956 359 VETERANS BLVD. SE DECISION MADE: 11-FEB-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CO HWA TEH INDUSTRIAL SDN. BHD. 510(k) NO: K994432(TRADITIONAL) ATTN: K. KARUNAKARAN PHONE NO : 603 871 7351 LOT 187, SUNGAI DAHAR SE DECISION MADE: 16-FEB-00 45600 BATANG BERJUNTAI 510(k) STATEMENT SELANGOR DARUL EHSAN, MALAYSIA 45600 DEVICE: I-STAT SYSTEM I-STAT CORP. 510(k) NO: K992571(TRADITIONAL) ATTN: PAUL VANDERWERF PHONE NO : 609-443-9300 104 WINDSOR CENTER DR. SE DECISION MADE: 10-FEB-00 EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER TISSUE I.Z.I. CORP. 510(k) NO: K993742(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4321 SE DECISION MADE: 02-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: MR ENHANCER I.Z.I. CORP. 510(k) NO: K994117(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 410-451-0639 P.O. BOX 4321 SE DECISION MADE: 04-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM IMPLANT INNOVATIONS, INC. 510(k) NO: K994148(TRADITIONAL) ATTN: WILLIAM G CONETY PHONE NO : 561-776-6819 4555 RIVERSIDE DR. SE DECISION MADE: 01-FEB-00 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR ST IMPLEX CORP. 510(k) NO: K994076(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 18-FEB-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRACLIP TISSUE MARKER INRAD 510(k) NO: K993785(TRADITIONAL) ATTN: JOSEPH M MAZUREK PHONE NO : 616-554-7750 3956 44TH ST., S.E. SE DECISION MADE: 04-FEB-00 KENTWOOD, MI 49512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBC VRV, MODEL 1350 INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K992657(TRADITIONAL) ATTN: H. DAVID SHOCKLEY, JR. PHONE NO : 512-326-3244 4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 18-FEB-00 SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744 DEVICE: SYNERGY VLS CAP NUT MODELS 2206, 6102 INTERPORE CROSS INTL. 510(k) NO: K000236(SPECIAL) ATTN: LYNN M RODARTI PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 16-FEB-00 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT DOUBLESTRUT LD INTRATHERAPEUTICS, INC. 510(k) NO: K993904(TRADITIONAL) ATTN: CATHY YOHNK PHONE NO : 612-697-2003 651 CAMPUS DR. SE DECISION MADE: 01-FEB-00 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTION AF-1 WHEELCHAIR INVACARE CORP. 510(k) NO: K000174(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 P.O. BOX 4028 SE DECISION MADE: 18-FEB-00 ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JE 2000 JACK'S ELECTRODES 510(k) NO: K993878(TRADITIONAL) ATTN: ANTHONY R.H. FENDER PHONE NO : 626-798-3913 2227 EAST CRESCENT DR. SE DECISION MADE: 01-FEB-00 ALTADENA, CA 91001 510(k) STATEMENT DEVICE: RX G-UNIVERSAL JENERIC/PENTRON, INC. 510(k) NO: K000360(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 18-FEB-00 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS JENERIC/PENTRON, INC. 510(k) NO: K994435(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 10-FEB-00 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: MED-GUARD SURGEON'S GOWN KAPPLER USA 510(k) NO: K992445(TRADITIONAL) ATTN: PHILIP C MANN PHONE NO : 256-505-4166 70 GRIMES DR. SE DECISION MADE: 18-FEB-00 GUNTERSVILLE, AL 35976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA RIGID CULDOSCOPE AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K993804(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 07-FEB-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ AUTOCLAVABLE CAMERA HEAD KARL STORZ IMAGING, INC. 510(k) NO: K994090(TRADITIONAL) ATTN: TERRY FERNANDEZ PHONE NO : 805-968-5563 175 CREMONA DR. SE DECISION MADE: 04-FEB-00 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 KATECHO, INC. 510(k) NO: K993745(TRADITIONAL) ATTN: WARREN R WALTERS PHONE NO : 515-244-1212 2500 BELL AVE. SE DECISION MADE: 03-FEB-00 P.O. BOX 21247 510(k) STATEMENT DES MOINES, IA 50321 DEVICE: AUDIOSCREENER OAE KEDLY INC. 510(k) NO: K000184(TRADITIONAL) ATTN: RANDALL J KROHN PHONE NO : 636-349-7770 920 S. HIGHWAY DRIVE SE DECISION MADE: 11-FEB-00 ST. LOUIS, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES KLS-MARTIN L.P. 510(k) NO: K994154(TRADITIONAL) ATTN: ARTHUR WARD PHONE NO : 813-376-4154 3234 ELLA LANE SE DECISION MADE: 15-FEB-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GRE LATEXX PARTNERS, INC. 510(k) NO: K993912(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 09-FEB-00 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRABLATOR ELECTRODE LINVATEC CORP. 510(k) NO: K993885(TRADITIONAL) ATTN: LAURA SENEFF PHONE NO : 727-392-6464 11311 CONCEPT BLVD. SE DECISION MADE: 10-FEB-00 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER 6.0 SOFTWARE OPTION MARCONI MEDICAL SYSTEMS 510(k) NO: K000310(SPECIAL) ATTN: ELAINE K KEELER PHONE NO : 440-483-5591 595 MINER RD. SE DECISION MADE: 15-FEB-00 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIFICIAL TEETH (ACRYLIC TEETH) MASTERDENT LTDA. 510(k) NO: K992854(TRADITIONAL) ATTN: JUAN FERNANDO SALAZAR PHONE NO : 305-888-6557 7150 N.W. 72 AVE SE DECISION MADE: 07-FEB-00 MIAMI, FL 33166 510(k) STATEMENT DEVICE: MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 MEDEFIL, INC. 510(k) NO: K993515(TRADITIONAL) ATTN: PRADEEP AGGARWAL PHONE NO : 847-895-3000 492 LUNT AVENUE SE DECISION MADE: 25-FEB-00 SCHAUMBURG, IL 60193 510(k) STATEMENT DEVICE: MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE MEDI-CULT A/S 510(k) NO: K991329(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 25-FEB-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-CULT LIQUID PARAFFIN MEDI-CULT A/S 510(k) NO: K991330(TRADITIONAL) ATTN: RONALD LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 25-FEB-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-CULT SPERM FREEZE MEDIUM MEDI-CULT A/S 510(k) NO: K991333(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 28-FEB-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-CULT FREEZING & THAWING PACKS MEDI-CULT A/S 510(k) NO: K991335(TRADITIONAL) ATTN: RTONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 28-FEB-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY CARE AND TUBING SETS MEDIONICS INTERNATIONAL INC. 510(k) NO: K994218(SPECIAL) ATTN: MAHESH A GARWAL PHONE NO : 905 472 6544 114 ANDERSON AVE. SE DECISION MADE: 10-FEB-00 MARKHAM, ONTARIO, CANADA L6E 1A5 510(k) STATEMENT DEVICE: AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAI MEDTAXX PARTNERS 510(k) NO: K994131(TRADITIONAL) ATTN: E. J SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 07-FEB-00 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K000274(SPECIAL) ATTN: JAMES BALUN PHONE NO : 616-643-5283 620 WATSON S.W. SE DECISION MADE: 10-FEB-00 GRAND RAPIDS, MI 49504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO URODYNAMIC SUITE, MODEL 9032E0101 MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K992715(TRADITIONAL) ATTN: ANN-CHRISTINE JONSSON PHONE NO : 454 457 9000 16-18 TONSBAKKEN SE DECISION MADE: 28-FEB-00 SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, USA 510(k) NO: K000094(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 08-FEB-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT MEDTRONIC, INC. 510(k) NO: K000210(SPECIAL) ATTN: MICHAEL JOHNSON PHONE NO : 612-514-9835 4000 LEXINGTON AVE. N SE DECISION MADE: 23-FEB-00 SHOREVIEW, MN 55126-2983 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CA MEDTRONIC, INC. 510(k) NO: K000379 ATTN: MARIE HOLM PHONE NO : 612-779-9183 4633 EAST LA PALMA AVE. SE DECISION MADE: 16-FEB-00 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER MEDTRONIC, INC. 510(k) NO: K000430(SPECIAL) ATTN: DEBRA KRIDNER PHONE NO : 714-779-3650 4633 EAST LA PALMA AVENUE SE DECISION MADE: 25-FEB-00 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDX INTECAM INTERFACE MEDX, INC. 510(k) NO: K993893(TRADITIONAL) ATTN: FLOYD ROWAN PHONE NO : 847-463-2020 3456 N. RIDGE AVE., #100 SE DECISION MADE: 10-FEB-00 ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETEK UBT_LITE BREATH TEST FOR H. PYLORI MERETEK 510(k) NO: K000316(SPECIAL) ATTN: KERRY BUSH PHONE NO : 615-333-6336 618 GRASSMERE PARK DRIVE SE DECISION MADE: 24-FEB-00 SUITE 20 510(k) SUMMARY AVAILABLE FROM FDA NASHVILLE, TN 37211 DEVICE: ISOCENTRIC BEAM CHECKER MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993959(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 718-567-3999 1470 OUTLOOK AVE. SE DECISION MADE: 14-FEB-00 BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMA-DOC PHANTOM MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K993960(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 718-567-3999 1470 OUTLOOK AVE. SE DECISION MADE: 14-FEB-00 BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-TORQ MICRO MOTORS, INC. 510(k) NO: K000120(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 03-FEB-00 IRVINE, CA 92606-1849 510(k) STATEMENT DEVICE: MA-300 ELECTROMYOGRAPHY SYSTEM MOTION LAB SYSTEMS, INC. 510(k) NO: K000220(TRADITIONAL) ATTN: EDMUND CRAMP PHONE NO : 225-928-4248 4326 PINE PARK DR. SE DECISION MADE: 24-FEB-00 BATON ROUGE, LA 70809-2397 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAC-63 KNEE ARRAY COIL MRI DEVICES CORP. 510(k) NO: K993898(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402 N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 04-FEB-00 JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT WAUKESHA, WI 53186 DEVICE: HSV-2 ELISA IGG, MODEL EL0920G MRL DIAGNOSTICS 510(k) NO: K993724(TRADITIONAL) ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900 10703 PROGRESS WAY SE DECISION MADE: 01-FEB-00 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSV-1 ELISA IGG, MODEL EL0910G MRL DIAGNOSTICS 510(k) NO: K993754(TRADITIONAL) ATTN: MICHAEL J WAGNER PHONE NO : 714-220-1900 10703 PROGRESS WAY SE DECISION MADE: 09-FEB-00 CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.CO.S SCREW NEWDEAL S.A. 510(k) NO: K993762(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-519-1098 9109 COPENHAVER DRIVE SE DECISION MADE: 04-FEB-00 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAC' PIN NEWDEAL S.A. 510(k) NO: K993910(TRADITIONAL) ATTN: NORMAN F ESTRIN PHONE NO : 301-519-1098 9109 COPENHAVER DRIVE SE DECISION MADE: 01-FEB-00 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M NIKOMED U.S.A., INC. 510(k) NO: K000079(SPECIAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 04-FEB-00 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO INSULIN SYRINGE NIPRO MEDICAL CORP. 510(k) NO: K000144(TRADITIONAL) ATTN: GARY GOLDSMITH PHONE NO : 888-647-7698 3150 NW 107TH AVE. SE DECISION MADE: 11-FEB-00 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO BLOOD COLLECTION NEEDLE NIPRO MEDICAL CORP. 510(k) NO: K992699(TRADITIONAL) ATTN: KAELYN HADLEY PHONE NO : 606-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 14-FEB-00 LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, NMT MEDICAL, INC. 510(k) NO: K994191(TRADITIONAL) ATTN: RONALD D ARKIN PHONE NO : 770-565-6166 1733 CANTON LN SE DECISION MADE: 08-FEB-00 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARSPO2, MODEL 2001 NOVAMETRIX MEDICAL SYSTEMS, INC. 510(k) NO: K993979(ABBREVIATED) ATTN: ROBERT H SCHIFFMAN PHONE NO : 203-265-7701 56 CARPENTER LANE SE DECISION MADE: 22-FEB-00 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM OPTIMAL IMAGING SYSTEMS INC. 510(k) NO: K000034(TRADITIONAL) ATTN: JORGE MILLIAN PHONE NO : 305-717-0039 9344 NW 13TH STREET SE DECISION MADE: 24-FEB-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33172 DEVICE: ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) ORATEC INTERVENTIONS, INC. 510(k) NO: K992805(TRADITIONAL) ATTN: JENNIFER BRENNAN PHONE NO : 650-369-9904 3700 HAVEN CT. SE DECISION MADE: 04-FEB-00 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT SV ORGANON TEKNIKA CORP. 510(k) NO: K994343(TRADITIONAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 10-FEB-00 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRYSPOT E.COLI 0157 KIT OXOID, LTD. 510(k) NO: K993401(TRADITIONAL) ATTN: AMANDA SHEPPARD PHONE NO : 441 256 841144 WADE RD. SE DECISION MADE: 28-FEB-00 BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT DEVICE: LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE P.T. MAJA AGUNG LATEXINDO 510(k) NO: K994255(TRADITIONAL) ATTN: EMMY TJOENG PHONE NO : 626-913-1798 889 SOUTH AZUSA AVENUE SE DECISION MADE: 07-FEB-00 INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993779(ABBREVIATED) ATTN: VIJAY MAHAL PHONE NO : 617-973-7157 7 RIVERVIEW ROAD SE DECISION MADE: 02-FEB-00 FRAMINGHAM, MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993781(ABBREVIATED) ATTN: VIJAY MAHAL PHONE NO : 617-973-7157 7 RIVERVIEW ROAD SE DECISION MADE: 02-FEB-00 FRAMINGHAM, MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOX P.T. VONIX LATEXINDO CONDOM (RUBBE510(k) NO: K993782(ABBREVIATED) ATTN: VIJAY MAHAL PHONE NO : 617-973-7157 7 RIVERVIEW ROAD SE DECISION MADE: 02-FEB-00 FRAMINGHAM, MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIC HEMOSTASIS THROMBOPLASTIN D PACIFIC HEMOSTASIS 510(k) NO: K994100(TRADITIONAL) ATTN: LAURA A WORFOLK PHONE NO : 800-528-0494 11515 VANSTORY DR. SE DECISION MADE: 18-FEB-00 HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAM PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993918(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 011 606 6313122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 10-FEB-00 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: RESIN TOOTH BONDING AGENT PARKELL, INC. 510(k) NO: K994302(TRADITIONAL) ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134 155 SCHMITT BLVD. SE DECISION MADE: 07-FEB-00 P.O. BOX 376 510(k) SUMMARY AVAILABLE FROM FDA FARMINGDALE, NY 11735 DEVICE: RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES W PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K994201(TRADITIONAL) ATTN: PETER YEW NIENG CHOON PHONE NO : 606 677 2781 LOT 110, LORONG SENAWANG 4/3 SE DECISION MADE: 07-FEB-00 SENAWANG INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA SEREMBAN, MALAYSIA 70450 DEVICE: QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 PHAMATECH 510(k) NO: K000131(SPECIAL) ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840 9265 ACTIVITY RD., #112-113 SE DECISION MADE: 04-FEB-00 SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, PHARMACIA & UPJOHN CO. 510(k) NO: K000132(TRADITIONAL) ATTN: KAREN E MATIS PHONE NO : 614-794-3324 5094 ST. ANDREWS DRIVE SE DECISION MADE: 18-FEB-00 WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTURIS SUITE PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K994210(TRADITIONAL) ATTN: FRANK GIANELLI PHONE NO : 203-926-7031 710 BRIDGEPORT AVENUE SE DECISION MADE: 04-FEB-00 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484 DEVICE: GLORY PILLAR TECHNOLOGY, INC. 510(k) NO: K994127(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 316-325-2629 1101 ILLINOIS SE DECISION MADE: 03-FEB-00 NEODESHA, KS 66757 510(k) STATEMENT DEVICE: PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMP PLAYTIME PRODUCTS, INC. 510(k) NO: K993794(TRADITIONAL) ATTN: MARK ROSENGARTEN PHONE NO : 201-785-8040 TECHNICAL CENTER SE DECISION MADE: 07-FEB-00 75 COMMERCE DRIVE 510(k) SUMMARY AVAILABLE FROM FDA ALLENDALE, NJ 07401-1600 DEVICE: THE MARGRON HIP REPLACEMENT SYSTEM PORTLAND ORTHOPAEDICS PTY. LTD. 510(k) NO: K992815(TRADITIONAL) ATTN: RONALD SEKEL PHONE NO : 612 958 82121 SUITE 3 LEVEL 5 ST. GEORGE SE DECISION MADE: 07-FEB-00 PRIVATE HOSPITAL 1 SOUTH ST. 510(k) SUMMARY AVAILABLE FROM FDA KOGARAH, NEW SOUTH WALES, AUSTRALIA NSW 2217 DEVICE: PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROBLEM SOLVING CONCEPTS, INC. 510(k) NO: K993750(TRADITIONAL) ATTN: THOMAS M MCCLELLAND PHONE NO : 317-848-7431 1980 E. 116TH STREET SE DECISION MADE: 02-FEB-00 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WIT PULPDENT CORP. 510(k) NO: K994182(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617-926-6666 80 OAKLAND ST. SE DECISION MADE: 23-FEB-00 WATERTOWN, MA 02471-0780 510(k) STATEMENT DEVICE: MU PLUS RAD THERAPY SOLUTIONS, INC. 510(k) NO: K992689(TRADITIONAL) ATTN: STEVE GRUSE PHONE NO : 904-441-7400 738 ALDEN DRIVE SE DECISION MADE: 10-FEB-00 ORMOND BEACH, FL 32176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PA RD MEDICAL MFG., INC. 510(k) NO: K000017(ABBREVIATED) ATTN: CARLOS A RODRIQUEZ PHONE NO : 787-742-3800 BO. FULLADOSA SE DECISION MADE: 10-FEB-00 CULEBRA, PR 00775 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND REMED PHARMA 510(k) NO: K993390(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 14-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AN REMED PHARMA 510(k) NO: K993395(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 15-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA 510(k) NO: K993396(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 15-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMM REMED PHARMA 510(k) NO: K993404(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 15-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT REMED PHARMA 510(k) NO: K993405(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 15-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT REMED PHARMA 510(k) NO: K993408(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 15-FEB-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: ACCU-CHEK COMPLETE METER ROCHE DIAGNOSTICS CORP. 510(k) NO: K000364(SPECIAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 23-FEB-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK ADVANTAGE METER ROCHE DIAGNOSTICS CORP. 510(k) NO: K000365(SPECIAL) ATTN: MIKE FLIS PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 23-FEB-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYON TRANSFER CATHETERS/SETS ROCKET MEDICAL PLC 510(k) NO: K994327(TRADITIONAL) ATTN: LES TODD PHONE NO : 011 441 914166776 TYNE & WEAR SE DECISION MADE: 28-FEB-00 WASHINGTON, UNITED KINGDOM NE37 1N510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRS-TITAN ROTEC MEDIZINTECHNIK GMBH 510(k) NO: K992359(TRADITIONAL) ATTN: ING ULRICH HOLZWARTH PHONE NO : 499 135 3215 AM MUHLBERG 31 SE DECISION MADE: 18-FEB-00 WEISENDORF, GERMANY D-91084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOCATH RUSCH INTL. 510(k) NO: K000070(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 18-FEB-00 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGIL RUSCH INTL. 510(k) NO: K993786(TRADITIONAL) ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706 TALL PINES PARK SE DECISION MADE: 02-FEB-00 JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYALURONIDASE, 80 U/ML SAGE BIOPHARMA 510(k) NO: K991393(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 02-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L SAGE BIOPHARMA 510(k) NO: K991396(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 15-FEB-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: EU-TTG IGA ELISA SCIMEDX CORP. 510(k) NO: K994379(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 18-FEB-00 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS SEIN ELECTRONICS CO., LTD. 510(k) NO: K991397(TRADITIONAL) ATTN: PHONE NO : 1540 BARCLAY BLVD. SE DECISION MADE: 11-FEB-00 BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM SENDX MEDICAL, INC. 510(k) NO: K994346(TRADITIONAL) ATTN: MARTIN SELLERS PHONE NO : 760-603-3407 1945 PALOMAR OAKS WAY SE DECISION MADE: 01-FEB-00 CARLSBAD, CA 92009 510(k) STATEMENT DEVICE: POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K994136(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVE. DE LA D' EMERALD SE DECISION MADE: 03-FEB-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K992979(TRADITIONAL) ATTN: JULIA WU PHONE NO : 862 162 095147 NO. 1 NEW DISTRICT SE DECISION MADE: 09-FEB-00 ZHU HANG CHEN 510(k) STATEMENT JINSHAN HSIEN, SHANGHAI, CHINA DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA SHEN WEI (USA), INC. 510(k) NO: K993876(TRADITIONAL) ATTN: BELLE L CHOU PHONE NO : 510-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 07-FEB-00 UNION CITY, CA 94587 510(k) STATEMENT DEVICE: SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LA SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K000156(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 18-FEB-00 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LAT SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K000217(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 18-FEB-00 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT EAGLE PLASTIC P510(k) NO: K000166(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 13945 MAGNOLIA AVENUE SE DECISION MADE: 22-FEB-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K994206(TRADITIONAL) ATTN: GUI-XI LIU PHONE NO : 011 863 113613127 NO. 135 XIN-HUA WEST ROAD SE DECISION MADE: 07-FEB-00 SHIJIAZHUANG CITY 510(k) STATEMENT HEBEI PROVINCE, CHINA 050081 DEVICE: SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLO SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K994222(TRADITIONAL) ATTN: GUI-XI LIU PHONE NO : 011 863 113613127 NO. 135 XIN-HUA WEST RD. SE DECISION MADE: 07-FEB-00 SHIJIAZHUANG, CHINA 050081 510(k) STATEMENT DEVICE: PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSUL SHIN CHANG MEDICAL CO., LTD. 510(k) NO: K993017(TRADITIONAL) ATTN: JAN J FRANK PHONE NO : 801-263-0975 3762 SOUTH 150 EAST SE DECISION MADE: 25-FEB-00 SALT LAKE CITY, UT 84115 510(k) STATEMENT DEVICE: SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K993974(TRADITIONAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 22-FEB-00 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K994315(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVENUE SOUTH SE DECISION MADE: 04-FEB-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMS PORTEX ANESTHESIA CATHETER SIMS PORTEX, INC. 510(k) NO: K994275(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 22-FEB-00 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEREC 3 SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K994172(SPECIAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 08-FEB-00 NORTH ATTLEBORO, MA 02760 510(k) STATEMENT DEVICE: SD-730 IF-SDS, PERFECT PULSE IF-SDS SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K992652(TRADITIONAL) ATTN: GEORGE K.C. CHEN PHONE NO : 011 886 225979005 34 CHUNG SHAN NORTH RD., SE DECISION MADE: 03-FEB-00 12TH FL., SEC. 3 510(k) STATEMENT TAIPEI, CHINA (TAIWAN) DEVICE: CAP PORP, CAP TORP SMITH & NEPHEW ENT. 510(k) NO: K000256(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0279 2925 APPLING RD. SE DECISION MADE: 11-FEB-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIAL HEAD PROSTHESIS SMITH & NEPHEW, INC. 510(k) NO: K992220(ABBREVIATED) ATTN: JANET JOHNSON GREEN PHONE NO : 901-396-2121 1450 E. BROOKS ROAD SE DECISION MADE: 25-FEB-00 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & M SMITH & NEPHEW, INC. 510(k) NO: K994143(TRADITIONAL) ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS ROAD SE DECISION MADE: 18-FEB-00 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX SMITH & NEPHEW, INC. 510(k) NO: K994202(TRADITIONAL) ATTN: NICHOLAS CONDAKES PHONE NO : 508-261-3770 130 FORBES BLVD. SE DECISION MADE: 25-FEB-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP MODEL 5 SNAP LABORATORIES, L.L.C. 510(k) NO: K992322(TRADITIONAL) ATTN: GIL RAVIV PHONE NO : 847-657-8100 3633 WEST LAKE AVE., SUITE 406 SE DECISION MADE: 02-FEB-00 GLENVIEW, IL 60025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY SPECIALTY ULTRAVISION, INC. 510(k) NO: K992787(TRADITIONAL) ATTN: IVALEE I COHEN PHONE NO : 408-341-0700 307 ORCHARD CITY DRIVE SE DECISION MADE: 02-FEB-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CAMPBELL, CA 95008 DEVICE: SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES F SPECIALTY ULTRAVISION, INC. 510(k) NO: K993580(TRADITIONAL) ATTN: RICHARD LIPPMAN PHONE NO : 408-341-0700 307 ORCHARD CITY DRIVE SE DECISION MADE: 02-FEB-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CAMPBELL, CA 95008 DEVICE: BILICHEK NON-INVASIVE BILIRUBIN ANALYZER SPECTRX, INC. 510(k) NO: K994438(TRADITIONAL) ATTN: JAMES R VEALE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 04-FEB-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL ST. GEORGE TECHNOLOGY, INC. 510(k) NO: K992176(TRADITIONAL) ATTN: VERNON WATKINS PHONE NO : 910-397-0781 P.O. BOX 2849 SE DECISION MADE: 10-FEB-00 WILMINGTON, NC 28402-2849 510(k) STATEMENT DEVICE: SJM TAILOR ANNULOPLASTY RING, MODEL TARN ST. JUDE MEDICAL, INC. 510(k) NO: K000119(SPECIAL) ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029 ONE LILLEHEI PLAZA SE DECISION MADE: 17-FEB-00 ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONEFLOW STI MEDICAL 510(k) NO: K980951(TRADITIONAL) ATTN: LAUREN R ZIEGLER PHONE NO : 973-857-3414 908 POMPTON AVE. SE DECISION MADE: 25-FEB-00 CEDAR GROVE, NJ 07009 510(k) STATEMENT DEVICE: CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION STRIETER CLINICAL RESEARCH LABORAT510(k) NO: K994021(TRADITIONAL) ATTN: JAMES F STRIETER PHONE NO : 800-851-4557 222 VANDALIA STREET SE DECISION MADE: 22-FEB-00 COLLINSVILLE, IL 62234 510(k) STATEMENT DEVICE: LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM STRYKER INSTRUMENTS 510(k) NO: K993990(TRADITIONAL) ATTN: KRISTYN R KELLEY PHONE NO : 800-253-7370 4100 EAST MILHAM AVE. SE DECISION MADE: 22-FEB-00 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL SURGICAL INSTRUMENT SYSTEMS (SIS),510(k) NO: K993190(TRADITIONAL) ATTN: JUDY GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 10-FEB-00 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATI SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K994421(TRADITIONAL) ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100 6509 AIRPORT RD. SE DECISION MADE: 23-FEB-00 MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEALTHSTATION TREATMENT GUIDANCE PLATFORM SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992461(TRADITIONAL) ATTN: ROGER N WHITE PHONE NO : 303-439-9709 530 COMPTON ST. SE DECISION MADE: 22-FEB-00 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTRALON NYLON SUTURES SUTRATEC, INC. 510(k) NO: K994176(TRADITIONAL) ATTN: JONATHAN GREEN PHONE NO : 202-966-3790 4740 CONNECTICUT AVE. N.W. SE DECISION MADE: 08-FEB-00 SUITE 708 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20008 DEVICE: SUTRASILK SILK SUTURE SUTRATEC, INC. 510(k) NO: K994177(TRADITIONAL) ATTN: JONATHAN GREEN PHONE NO : 202-966-3790 4740 CONNECTICUT AVE. N.W. SE DECISION MADE: 08-FEB-00 SUITE 708 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20008 DEVICE: SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS SYNTHES (USA) 510(k) NO: K000089(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 03-FEB-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICK'X SYNTHES SPINE 510(k) NO: K992739(TRADITIONAL) ATTN: JONATHAN M GILBERT PHONE NO : 610-647-9700 P.O. BOX 0548 SE DECISION MADE: 08-FEB-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL SYVA CO. 510(k) NO: K993980(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 01-FEB-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL SYVA CO. 510(k) NO: K993981(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA RD. SE DECISION MADE: 01-FEB-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, TANDEM MEDICAL, INC. 510(k) NO: K993832(TRADITIONAL) ATTN: ALBERT MISAJON PHONE NO : 858-673-3900 15910 BERNARDO CENTER DR. SE DECISION MADE: 09-FEB-00 SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTENDED STRAIGHT ATTACHMENT TEAM TECHNOLOGIES, INC. 510(k) NO: K994024(TRADITIONAL) ATTN: BOB WALTON PHONE NO : 423-587-2199 5949 COMMERCE BLVD. SE DECISION MADE: 03-FEB-00 MORRISTOWN, TN 37814 510(k) STATEMENT DEVICE: GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 TECO DIAGNOSTICS 510(k) NO: K000102(SPECIAL) ATTN: DINDO CARRILLO PHONE NO : 714-693-7788 4925 EAST HUNTER AVE. SE DECISION MADE: 08-FEB-00 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTE TEKMEDIC (M) SDN BHD 510(k) NO: K994250(TRADITIONAL) ATTN: KOK-KEE HON PHONE NO : 703-941-7576 6324 MEETING HOUSE WAY SE DECISION MADE: 07-FEB-00 ALEXANDRIA, VA 22312-1718 510(k) STATEMENT DEVICE: TED 200T7 OXYGEN MONITOR TELEDYNE ELECTRONIC TECHNOLOGIES 510(k) NO: K990403(TRADITIONAL) ATTN: RAY KHAJAVI PHONE NO : 626-934-1502 16830 CHESTNUT STREET SE DECISION MADE: 03-FEB-00 CITY OF INDUSTRY, CA 510(k) STATEMENT DEVICE: ILM ENDOTRACHEAL TUBE THE LARYNGEAL MASK CO.,LTD. 510(k) NO: K991580(TRADITIONAL) ATTN: ROBERT GAINES COOPER PHONE NO : 001 357 2670000 12300 TWINBROOK PARKWAY SE DECISION MADE: 04-FEB-00 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/S THE PROMETHEUS GROUP 510(k) NO: K993976(TRADITIONAL) ATTN: RICHARD HORTON PHONE NO : 781-582-2328 2 MALLARDS COVE SE DECISION MADE: 22-FEB-00 DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOGBONE ACFS THEKEN SURGICAL 510(k) NO: K994383(TRADITIONAL) ATTN: LUKAS EISERMANN PHONE NO : 330-753-7451 1100 NOLA AVENUE SE DECISION MADE: 04-FEB-00 BARBERTON, OH 44203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMACOL TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K992556(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600 7124 LA JOLLA BLVD. SE DECISION MADE: 17-FEB-00 LA JOLLA, CA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TMC-EASY-302 TMC MAGNETICS & MACHINERY CORP. 510(k) NO: K984565(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 16-FEB-00 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: TOKUYAMA ONE-UP-BOND F TOKUYAMA AMERICA, INC. 510(k) NO: K993917(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M STREET NW SE DECISION MADE: 02-FEB-00 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: EXCELART WITH PIANISSIMO TOSHIBA AMERICA MRI, INC. 510(k) NO: K993803(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 06-FEB-00 SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYPROPYLENE TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993997(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 04-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NYLON TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993998(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 04-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K993999(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 04-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYESTER TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994000(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 04-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYGLYCOLIC ACID TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994001(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 09-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAIN/CHROMIC CATGUT TRADING CONSULTANTS AND DISTRIBUTO510(k) NO: K994002(TRADITIONAL) ATTN: MAIN M GHAZAL PHONE NO : 847-265-7676 157 WINDDANCE DR. SE DECISION MADE: 04-FEB-00 CHICAGO, IL 60046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E.N.S.I. SYRINGE TRI-JECT INTL. CORP. 510(k) NO: K000572(TRADITIONAL) ATTN: PETER G LEMIN PHONE NO : 253-845-8400 310 MERIDIAN N., SUITE 6 SE DECISION MADE: 24-FEB-00 PUYALLUP, WA 98371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE-BIOGLASS BONE GRAFT PARTICULATE U.S. BIOMATERIALS CORP. 510(k) NO: K000149(SPECIAL) ATTN: ALBERT FOSMOE PHONE NO : 904-462-7660 ONE PROGRESS BLVD. #23 SE DECISION MADE: 07-FEB-00 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASEAL XT PLUS ULTRADENT PRODUCTS, INC. 510(k) NO: K993846(TRADITIONAL) ATTN: SCOTT E MOORE PHONE NO : 801-572-4200 505 WEST 10200 SOUTH SE DECISION MADE: 16-FEB-00 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT ULTRADENT PRODUCTS, INC. 510(k) NO: K994261(TRADITIONAL) ATTN: SCOTT E MOORE PHONE NO : 800-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 02-FEB-00 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: CAVERMAP SURGICAL AID UROMED CORP. 510(k) NO: K993436(TRADITIONAL) ATTN: FREDERICK TOBIA PHONE NO : 781-762-2080 1400 PROVIDENCE HWY., BLDG.2 SE DECISION MADE: 11-FEB-00 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNA 5000 PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K000002(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 23-FEB-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNA 5000 PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K994345(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 14-FEB-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISSA PHAROS VAMS TEC, D.O.O. 510(k) NO: K994054(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 14-FEB-00 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: VANNA BATHING SYSTEM VANCARE, INC. 510(k) NO: K993872(TRADITIONAL) ATTN: JAMES A VANDERHEIDEN PHONE NO : 402-694-4525 1515 1ST ST. SE DECISION MADE: 16-FEB-00 AURORA, NE 68818 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMAVISION VARIAN ASSOC., INC. 510(k) NO: K992751(TRADITIONAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3045 HANOVER STREET SE DECISION MADE: 16-FEB-00 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEIN ENTRY INDICATOR DEVICE (VEID) VASCULAR TECHNOLOGIES LTD. 510(k) NO: K993995(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 979 20673 P.O.B. 454 SE DECISION MADE: 14-FEB-00 GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT DEVICE: LEMAITRE BALLOON CATHETER WITH IRRIGATION VASCUTECH, INC. 510(k) NO: K992940(TRADITIONAL) ATTN: TRENT G KAMKE PHONE NO : 781-221-2266 164 MIDDLESEX TURNPIKE SE DECISION MADE: 22-FEB-00 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND V VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K994318(TRADITIONAL) ATTN: SHARON BRIGGS PHONE NO : 904-443-1471 7500 CENTURION PKWY. SE DECISION MADE: 23-FEB-00 JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND V VISTAKON, JOHNSON & JOHNSON VISION510(k) NO: K994324(TRADITIONAL) ATTN: SHARON BRIGGS PHONE NO : 904-443-1471 7500 CENTURION PKWY. SE DECISION MADE: 23-FEB-00 JACKSONVILLE, FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEEN-ABLE VITAL SIGNS, INC. 510(k) NO: K994044(TRADITIONAL) ATTN: ANTHONY MARTINO PHONE NO : 973-790-1330 20 CAMPUS RD. SE DECISION MADE: 25-FEB-00 TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH MICRO VITALOGRAPH INC. 510(k) NO: K991412(TRADITIONAL) ATTN: PHIL HEMES PHONE NO : 913-888-4221 8347 QUIVIRA RD. SE DECISION MADE: 04-FEB-00 LENEXA, KS 66215 510(k) STATEMENT DEVICE: ASP-100, MODEL 2100 VITROLIFE AB 510(k) NO: K991345(TRADITIONAL) ATTN: GRAY L YINGLING PHONE NO : 202-496-7645 MOLNDALSVAGEN 30 SE DECISION MADE: 18-FEB-00 GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PH-100, MODEL 2104 VITROLIFE AB 510(k) NO: K991346(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-496-7645 MOLNDALSVAGEN 30 SE DECISION MADE: 24-FEB-00 GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVOIL-150, MODEL 5002 VITROLIFE AB 510(k) NO: K991351(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-496-7500 MOLNDALSVAGEN 30 SE DECISION MADE: 25-FEB-00 GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARABESK TOP VOCO GMBH 510(k) NO: K994268(TRADITIONAL) ATTN: EVAN DICK PHONE NO : 314-721-0112 7527 WESTMORELAND AVE. SE DECISION MADE: 03-FEB-00 ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARABESK FLOW VOCO GMBH 510(k) NO: K994304(TRADITIONAL) ATTN: EVAN DICK PHONE NO : 314-721-0112 7527 WESTMORELAND AVE. SE DECISION MADE: 07-FEB-00 ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) W.L. GORE & ASSOCIATES,INC 510(k) NO: K000185(SPECIAL) ATTN: R. LARRY PRATT PHONE NO : 520-779-2771 3450 WEST KILTIE LANE SE DECISION MADE: 14-FEB-00 P.O. BOX 500 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF, AZ 86002-0500 DEVICE: WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1 WHITESIDE BIOMECHANICS, INC. 510(k) NO: K993903(TRADITIONAL) ATTN: DEBRA MEYER PHONE NO : 314-996-8540 12634 OLIVE BLVD. SE DECISION MADE: 14-FEB-00 ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHRO-SURGIMAT-A103 WOM GMBH 510(k) NO: K000153(SPECIAL) ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188 194 BRANCH ST SE DECISION MADE: 08-FEB-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCON-T DISTAL RADIAL PLATE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K994061(TRADITIONAL) ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-4620 5677 AIRLINE RD. SE DECISION MADE: 14-FEB-00 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDX-60 INTRAORAL X-RAY X-CEL X-RAY CORP. 510(k) NO: K993958(TRADITIONAL) ATTN: WILLIAM W MORRIS PHONE NO : 815-455-2470 4220 WALLER DR., P.O. BOX 1857 SE DECISION MADE: 14-FEB-00 CRYSTAL LAKE, IL 60039-1857 510(k) STATEMENT DEVICE: FRONTAL SINUS TREPHINATION CANNULA XOMED, INC. 510(k) NO: K994262(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 08-FEB-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K000362(SPECIAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 18-FEB-00 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA T ZEUS SCIENTIFIC, INC. 510(k) NO: K000363(SPECIAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 P.O. BOX 38 SE DECISION MADE: 18-FEB-00 RARITAN, NJ 08869 510(k) STATEMENT DEVICE: ZOLL M SERIES ETCO2 OPTION ZOLL MEDICAL CORP. 510(k) NO: K993036(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 781-229-0020 32 SECOND AVE. SE DECISION MADE: 28-FEB-00 BURLINGTON, MA 01803 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 313 TOTAL WITH SUMMARIES 223 TOTAL WITH STATEMENTS 90
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