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Medical Devices
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November 1999 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-NOV-99 THROUGH 30-NOV-99
DEVICE: 1818 TENS UNIT
138 MEDICAL SUPPLIES, INC. 510(k) NO: K992709(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-NOV-99
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY-JET DEVICE
A.STEIN-REGULATORY AFFAIRS CONSULT510(k) NO: K972383(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 979 20673
P.O.B. 454 SE DECISION MADE: 23-NOV-99
GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT
DEVICE: ETEST FOR QUINUPRISTIN/DALFOPRISTIN
AB BIODISK 510(k) NO: K992993(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760
DALVAGEN 10 SE DECISION MADE: 16-NOV-99
SOLNA, SWEDEN S-169 56 510(k) STATEMENT
DEVICE: ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
ABBOTT LABORATORIES, INC. 510(k) NO: K991483(TRADITIONAL)
ATTN: KATHERINE M WORTLEY PHONE NO : 847-938-7707
200 ABBOTT PARK ROAD SE DECISION MADE: 01-NOV-99
ABBOTT PARK, IL 60064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
ABBOTT LABORATORIES, INC. 510(k) NO: K992710(TRADITIONAL)
ATTN: KATHERINE M WORTLEY PHONE NO : 847-938-7707
DEPT 9VC, BIDG. AP31 SE DECISION MADE: 24-NOV-99
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6200
DEVICE: AD-TECH'S FORAMEN OVALE ELECTRODE
AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K990788(TRADITIONAL)
ATTN: DAVID PUTZ PHONE NO : 414-634-1555
1901 WILLIAM STREET SE DECISION MADE: 02-NOV-99
RACINE, WI 53404-1876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
ADVANCED DIAGNOSTICS & INTERVENTIO510(k) NO: K992621(TRADITIONAL)
ATTN: ANTONY FENDER PHONE NO : 310-373-6769
216 VIA LINDA VISTA SE DECISION MADE: 08-NOV-99
REDONDO BEACH, CA 90277 510(k) STATEMENT
DEVICE: MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
ADVANCED UROSCIENCE INC. 510(k) NO: K993459(SPECIAL)
ATTN: KAREN E PETERSON PHONE NO : 651-653-8512
1290 HAMMOND RD. SE DECISION MADE: 05-NOV-99
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMASEAL & CIDE
ADVANTAGE DENTAL PRODUCTS, INC. 510(k) NO: K990779(TRADITIONAL)
ATTN: INGRID K PELERIN PHONE NO : 800-388-6319
4498 KLAIS DR. SE DECISION MADE: 17-NOV-99
CLARKSTON, MI 48348 510(k) STATEMENT
DEVICE: PHACOLASE ER: YAG LASER
AESCULAP-MEDITEC GMBH 510(k) NO: K991993(TRADITIONAL)
ATTN: WILLIAM T KELLEY PHONE NO : 949-660-2770
2525 MCGAW AVENUE SE DECISION MADE: 17-NOV-99
IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET EN
ALLERGY DIRECT 510(k) NO: K992702(TRADITIONAL)
ATTN: GAVIN MCLACLAN PHONE NO : 816-356-5515
8800 EAST 63RD STREET SE DECISION MADE: 08-NOV-99
KANSAS CITY, MO 64133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOGEL HIGH RISK & CHEMOTHERAPHY GLOVES
AMPRI RUBBERWARE INDUSTRIES SDN BH510(k) NO: K990677(TRADITIONAL)
ATTN: LI KIM PHNG PHONE NO : 603 807 3778
LOT B5 & B6, PHASE II, SE DECISION MADE: 01-NOV-99
KAWASAN PERINDUSTRIAN MIEL 510(k) STATEMENT
BATANG KALI, SELANGOR, MALAYSIA 44300
DEVICE: SUTURE CLINCH
APPLIED MEDICAL RESOURCES 510(k) NO: K992852(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104 SE DECISION MADE: 22-NOV-99
LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI-GRAFT K DV PATCH
ATRIUM MEDICAL CORP. 510(k) NO: K992776(TRADITIONAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 16-NOV-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: AVOCET ACUSURE SYSTEM
AVOCET MEDICAL, INC. 510(k) NO: K991286(TRADITIONAL)
ATTN: JUDITH BLUNT PHONE NO : 408-574-6615
100 GREAT OAKS BLVD. SE DECISION MADE: 18-NOV-99
SAN JOSE, CA 95119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXON MP-1 MICROPOSITIONER
AXON INSTRUMENTS INC. 510(k) NO: K990683(TRADITIONAL)
ATTN: ANDREW L BLATZ PHONE NO : 650-571-9400
1101 CHESS DR. SE DECISION MADE: 03-NOV-99
FOSTER CITY, CA 94404-1102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
BAXTER HEALTHCARE CORP. 510(k) NO: K992894(TRADITIONAL)
ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335
1620 WAUKEGAN RD., MPR-D1 SE DECISION MADE: 24-NOV-99
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED BLOOD RECIPIENT SET
BAXTER HEALTHCARE CORP. 510(k) NO: K993120(TRADITIONAL)
ATTN: JUDY KANNENBERG PHONE NO : 847-270-5976
RT. 120 & WILSON RD. SE DECISION MADE: 17-NOV-99
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
BAXTER HEALTHCARE CORP. 510(k) NO: K993387(SPECIAL)
ATTN: VICKI L DREWS PHONE NO : 847-270-5916
RT. 120 & WILSON RD. SE DECISION MADE: 01-NOV-99
ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROALBUSTIX REAGENT STRIPS (OTC)
BAYER CORP. 510(k) NO: K991315(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 12-NOV-99
ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
BAYER CORP. 510(k) NO: K991907(TRADITIONAL)
ATTN: GABRIEL J MURACA, JR PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 09-NOV-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
BAYER CORP. 510(k) NO: K992136(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 09-NOV-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW MULTIPLES REAGENT STRIPS
BAYER CORP. 510(k) NO: K992257(TRADITIONAL)
ATTN: SYED ATAULLAH PHONE NO : 219-262-6865
1884 MILES AVE. SE DECISION MADE: 24-NOV-99
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
BECKMAN COULTER, INC. 510(k) NO: K993022(TRADITIONAL)
ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8505
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 09-NOV-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
BECKMAN COULTER, INC. 510(k) NO: K993023(TRADITIONAL)
ATTN: GAIL L EFEBVRE PHONE NO : 714-993-8503
200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 26-NOV-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS DRUG CALIBRATOR 2
BECKMAN COULTER, INC. 510(k) NO: K993473(TRADITIONAL)
ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 26-NOV-99
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERCID, 15 UG, BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K993186(TRADITIONAL)
ATTN: BRADFORD M SPRING PHONE NO : 410-316-4206
7 LOVETON CIRCLE SE DECISION MADE: 03-NOV-99
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AM
BECTON DICKINSON MICROBIOLOGY SYST510(k) NO: K984631(TRADITIONAL)
ATTN: COLLEEN ROHRBECK PHONE NO : 410-316-4988
7 LOVETON CIRCLE SE DECISION MADE: 04-NOV-99
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROG
BESGLOVE MEDICARE SDN. BHD. 510(k) NO: K993495(TRADITIONAL)
ATTN: LEE AIK LIM PHONE NO : 038 256 36162
LOT 6, JALAN P/2A SE DECISION MADE: 24-NOV-99
BANGI INDUSTRIAL ESTATE 510(k) STATEMENT
KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICR
BESGLOVE MEDICARE SDN. BHD. 510(k) NO: K993502(TRADITIONAL)
ATTN: LEE AIK LIM PHONE NO : 603 825 6361/2
LOT 6, JALAN P/2A SE DECISION MADE: 24-NOV-99
BANGI INDUSTRIAL ESTATE 510(k) STATEMENT
KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000
DEVICE: SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE D
BETTER WATER, INC. 510(k) NO: K992793(TRADITIONAL)
ATTN: MIKE S STERLING PHONE NO : 615-355-6063
698 SWAN DR. SE DECISION MADE: 16-NOV-99
SMYRNA, TN 37167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYPHOCHEK ANEMIA CONTROL, MODEL 500
BIO-RAD LABORATORIES, INC. 510(k) NO: K992741(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 09-NOV-99
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAD CODA NEONATAL GALT ASSAY
BIO-RAD LABORATORIES, INC. 510(k) NO: K993536(SPECIAL)
ATTN: ELIZABETH TANG PHONE NO : 510-741-6298
4000 ALFRED NOBEL DR. SE DECISION MADE: 04-NOV-99
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC
BIOMAT SCIENCES, INC. 510(k) NO: K992838(TRADITIONAL)
ATTN: IVAN STANGEL PHONE NO : 301-652-3327
5612 GLENWOOD RD SE DECISION MADE: 15-NOV-99
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE-STEP DOUBLE-CHEK PREGNANCY TEST
BIOMEDICAL PRODUCTS CORP. 510(k) NO: K992915(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
15 OAK STREET SE DECISION MADE: 18-NOV-99
BEVERLY FARMS, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILL
BIOMEDICS 510(k) NO: K992330(TRADITIONAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 23-NOV-99
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
BIOMET, INC. 510(k) NO: K990290(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-NOV-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED BMP TROCHANTERIC PLATES
BIOMET, INC. 510(k) NO: K993510(SPECIAL)
ATTN: FRED MCCLURE PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 16-NOV-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MENISCUS ARROW, MODELS 531110, 531113, 531116
BIONX IMPLANTS, LTD. 510(k) NO: K993453(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 09-NOV-99
HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33721
DEVICE: SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
BIOSAFE DIAGNOSTICS CORP. 510(k) NO: K991850(TRADITIONAL)
ATTN: STEVEN P TYRRELL PHONE NO : 847-821-7300
300 KNIGHTSBRIDGE PKWY., #150 SE DECISION MADE: 26-NOV-99
LINCOLNSHIRE, IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDTOX A OIA
BIOSTAR, INC. 510(k) NO: K991829(TRADITIONAL)
ATTN: ROGER C BRIDEN PHONE NO : 303-530-3888
6655 LOOKOUT RD. SE DECISION MADE: 02-NOV-99
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS
BIOTRONIK, INC. 510(k) NO: K993434(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 10-NOV-99
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT-CORE
BISCO, INC. 510(k) NO: K993488(TRADITIONAL)
ATTN: KATHRYN B PATTERSON PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 10-NOV-99
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIV
BOSTON SCIENTIFIC CORP. 510(k) NO: K992510(TRADITIONAL)
ATTN: RON BENNETT PHONE NO : 612-550-5642
5905 NATHAN LANE SE DECISION MADE: 18-NOV-99
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTELLATION CATHETERS, MODEL 8039
BOSTON SCIENTIFIC CORP. 510(k) NO: K992777(SPECIAL)
ATTN: STEVE JWANOUSKOS PHONE NO : 408-985-3529
2710 ORCHARD PKWY. SE DECISION MADE: 12-NOV-99
SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHA
BOSTON SCIENTIFIC CORPORATION NORT510(k) NO: K993648(SPECIAL)
ATTN: CYNDY ADAMS PHONE NO : 425-556-1570
17425 N.E. UNION HILL ROAD SE DECISION MADE: 24-NOV-99
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITRAKPLUS HOLTER RECORDER
BRAEMAR CORP. 510(k) NO: K993617(SPECIAL)
ATTN: DAVID NORBERG PHONE NO : 612-890-5135
11481 RUPP DRIVE SE DECISION MADE: 24-NOV-99
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DXP1000 HOLTER RECORDER
BRAEMAR CORP. 510(k) NO: K993618(SPECIAL)
ATTN: DAVID NORBERG PHONE NO : 612-890-5135
11481 RUPP DRIVE SE DECISION MADE: 24-NOV-99
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
BRAHMS DIAGNOSTICA, LLC 510(k) NO: K992790(TRADITIONAL)
ATTN: H. LEE HERRON PHONE NO : 770-449-7738
29 SOUTH PEACHTREE STREET SE DECISION MADE: 12-NOV-99
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
BRAHMS DIAGNOSTICA, LLC 510(k) NO: K992791(TRADITIONAL)
ATTN: H. LEE HERRON PHONE NO : 770-449-7738
29 SOUTH PEACHTREE STREET SE DECISION MADE: 12-NOV-99
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASAL AIRE
BREATHING TECHNOLOGIES CORP. 510(k) NO: K990659(TRADITIONAL)
ATTN: TERRY C MCMAHAON PHONE NO : 919-462-2214
11000 WESTON PARKWAY SE DECISION MADE: 26-NOV-99
CARY, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BRUNO POWERBASE, MODEL PSB-2200
BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K991954(TRADITIONAL)
ATTN: WILLIAM W BELSON III PHONE NO : 800-882-8183
1780 EXECUTIVE DR. SE DECISION MADE: 02-NOV-99
OCONOMOWOC, WI 53066 510(k) STATEMENT
DEVICE: ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION
C.R. BARD, INC. 510(k) NO: K992373(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR., SUITE 1 SE DECISION MADE: 05-NOV-99
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD HYDROPHILIC COATED GUIDE WIRES
C.R. BARD, INC. 510(k) NO: K993000(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR., SUITE 1 SE DECISION MADE: 02-NOV-99
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUUM ASSIST STABILIZER
CARDIO THORACIC SYSTEMS 510(k) NO: K992833(TRADITIONAL)
ATTN: MICHAEL BILLIG PHONE NO : 408-342-1700
10600 N. TANTAU AVENUE SE DECISION MADE: 10-NOV-99
CUPERTINO, CA 95014-0739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DOCUMENT THYROID CAL.VER
CASCO-NERL DIAGNOSTICS CORPORATION510(k) NO: K993014(TRADITIONAL)
ATTN: KAREN HICKEY PHONE NO : 207-878-7550
500 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 26-NOV-99
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K992449(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 445 7111
PENTLANDS SCIENCE PARK SE DECISION MADE: 24-NOV-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: AUTOSTAT II ANTI-GLIADIN IGA ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K993086(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 12-NOV-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: AUTOSTAT II ANTI-GLIADIN IGG ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K993087(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 12-NOV-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: COLORMAX COLOR VISION ENHANCEMENT LENSES
COLOR VISION TECHNOLOGIES, INC. 510(k) NO: K984219(TRADITIONAL)
ATTN: JULIE KIM PHONE NO : 714-730-6800
19726 COLIMA ROAD SE DECISION MADE: 18-NOV-99
SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA
ROWLAND HEIGHTS, CA 91748
DEVICE: ECG ELECTRODE (VARIOUS)
CONMED CORP. 510(k) NO: K991105(TRADITIONAL)
ATTN: IRA D DUESLER PHONE NO : 315-797-8375
310 BROAD ST. SE DECISION MADE: 26-NOV-99
UTICA, NY 13501-1203 510(k) STATEMENT
DEVICE: OPTILITE IX LASER SURGERY ACCESSORIES
CONVERGENT LASER TECHNOLOGIES 510(k) NO: K992866(TRADITIONAL)
ATTN: MARILYN M CHOU PHONE NO : 510-832-2130
900 ALICE STREET SE DECISION MADE: 18-NOV-99
OAKLAND, CA 94607 510(k) STATEMENT
DEVICE: METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FRE
COOPERVISION, INC. 510(k) NO: K993252(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 716-264-3210
711 NORTH ROAD SE DECISION MADE: 24-NOV-99
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
COPAN DIAGNOSTICS INC. 510(k) NO: K993161(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 09-NOV-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K993646(SPECIAL)
ATTN: ELENA JUGO PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 28-NOV-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
CORDIS WEBSTER, INC. 510(k) NO: K992965(TRADITIONAL)
ATTN: MARY ADAMS PHONE NO : 909-839-8604
4750 LITTLEJOHN ST. SE DECISION MADE: 26-NOV-99
BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE TAPER-FIT TOTAL HIP SYSTEM
CORIN U.S.A. 510(k) NO: K992234(TRADITIONAL)
ATTN: CRAIG CORRANCE PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 10-NOV-99
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
CORIN U.S.A. 510(k) NO: K992235(TRADITIONAL)
ATTN: CRAIG CORRANCE PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 23-NOV-99
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: CKHEMO, MODEL CKHEMO VERSION 1.0
CSAM, INC. 510(k) NO: K992255(TRADITIONAL)
ATTN: YOOBONG KIM PHONE NO : 319-344-7544
1890 14TH STREET SE DECISION MADE: 30-NOV-99
BETTENDORF, IA 52722 510(k) STATEMENT
DEVICE: SL990, SL980, SL950
CSO 510(k) NO: K992836(TRADITIONAL)
ATTN: R. BRENT MINER PHONE NO : 716-632-1988
197 BELVOIR ROAD SE DECISION MADE: 09-NOV-99
WILLIAMSVILLE, NY 14221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
DADE BEHRING, INC. 510(k) NO: K993174(TRADITIONAL)
ATTN: REDAMES RIESGO PHONE NO : 305-636-7727
1851 DELAWARE PKWY. SE DECISION MADE: 09-NOV-99
MIAMI, FL 33125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX FERRITIN
DADE BEHRING, INC. 510(k) NO: K993273(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 23-NOV-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
DADE BEHRING, INC. 510(k) NO: K993310(TRADITIONAL)
ATTN: DONNA A WOLF PHONE NO : 302-631-0384
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 30-NOV-99
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: IF8000
DAN MED, INC. 510(k) NO: K991241(TRADITIONAL)
ATTN: THOMAS SANDGAARD PHONE NO : 800-495-6670
4 WEST DRY CREEK CIRCLE SE DECISION MADE: 02-NOV-99
SUITE 260 510(k) STATEMENT
DENVER, CO 80120
DEVICE: ALARMVIEW SYSTEM
DATA CRITICAL CORP. 510(k) NO: K992848(TRADITIONAL)
ATTN: DREW WEAVER PHONE NO : 425-482-7000
19820 NORTH CREEK PKWY., #100 SE DECISION MADE: 19-NOV-99
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
DATEX-OHMEDA, INC. 510(k) NO: K992323(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 978-640-0460
3 HIGHWOOD DR. SE DECISION MADE: 01-NOV-99
TEWKSBURY, MA 01876 510(k) STATEMENT
DEVICE: IMPRESARIO
DEL MAR MEDICAL SYSTEMS, LLC. 510(k) NO: K993620(SPECIAL)
ATTN: NEVINE ERIAN PHONE NO : 949-250-3200
1621 ALTON PARKWAY SE DECISION MADE: 12-NOV-99
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX LOCATOR BINGO-1020
DENT CORP. RESEARCH & DEVELOPMENT 510(k) NO: K992233(TRADITIONAL)
ATTN: DAVID ALBELDA PHONE NO : 800-454-9244
7-11 SOUTH BROADWAY SE DECISION MADE: 30-NOV-99
WHITE PLAINS, NY 10601 510(k) STATEMENT
DEVICE: SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
DENTSPLY INTL. 510(k) NO: K992822(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE. SE DECISION MADE: 17-NOV-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY TOTAL ELBOW SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K992656(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 05-NOV-99
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROADRUNNER, PEP THERAPY DEVICE
DHD HEALTHCARE CORP. 510(k) NO: K991561(TRADITIONAL)
ATTN: LARRY WEINSTEIN PHONE NO : 800-847-8000
ONE MADISON ST. SE DECISION MADE: 10-NOV-99
WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K993251(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 17-NOV-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K993254(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 12-NOV-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRENDCARE CALIBRATOR MODEL SCU 7007
DIAMETRICS MEDICAL, LTD. 510(k) NO: K983198(TRADITIONAL)
ATTN: JAN WALTERS PHONE NO : 149-447-1671
SHORT STREET SE DECISION MADE: 23-NOV-99
HIGH WYCOMBE, BUCKS, UNITED KINGDO510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAISY PROTECTED SCALP VEIN SET
DIASOL INC. 510(k) NO: K992999(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 05-NOV-99
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: SHELLY PROTECTED AV FISTULA NEEDLE
DIASOL INC. 510(k) NO: K993187(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 05-NOV-99
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
DIASORIN INC. 510(k) NO: K993669(SPECIAL)
ATTN: JUDITH J SMITH PHONE NO : 301-497-0005
9175 GUILFORD RD., SUITE 100 SE DECISION MADE: 17-NOV-99
QUARRY PARK PLACE 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21046
DEVICE: DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
DIDECO S.P.A. 510(k) NO: K992599(ABBREVIATED)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 01-NOV-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYBRID CAPTURE II GC-ID
DIGENE CORP. 510(k) NO: K981485(TRADITIONAL)
ATTN: MARK A DEL VECCHIO PHONE NO : 301-470-6287
9000 VIRGINIA MANOR RD., #207 SE DECISION MADE: 29-NOV-99
BELTSVILLE, MD 20705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISETRONIC PEN P100
DISETRONIC MEDICAL SYSTEMS 510(k) NO: K993666(SPECIAL)
ATTN: LEE LEICHTER PHONE NO : 941-768-1118
7690 CAMERON CIRCLE SE DECISION MADE: 22-NOV-99
FT. MEYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECUSIT COMPOSITE REPAIR
DMG HAMBURG 510(k) NO: K992879(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 09-NOV-99
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER SCANNER HANDPIECE
DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K993146(TRADITIONAL)
ATTN: CAROL WERNECKE PHONE NO : 770-426-1315
1155 ROBERTS BLVD. SE DECISION MADE: 08-NOV-99
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE HYDROGEL
DUMEX MEDICAL SURGICAL PRODUCTS, L510(k) NO: K993119(TRADITIONAL)
ATTN: SAM LAKHANI PHONE NO : 416 299 4003
104 SHORTING RD. SE DECISION MADE: 23-NOV-99
SCARBOROUGH, ONTARIO, CANADA M1S 3510(k) STATEMENT
DEVICE: SITE-RITE 3 ULTRASOUND SYSTEM
DYMAX, CORP. 510(k) NO: K993624(TRADITIONAL)
ATTN: CHARLES MORREALE PHONE NO : 412-963-6884
271 KAPPA DR. SE DECISION MADE: 10-NOV-99
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI SPINELINK SYSTEM
EBI, L.P. 510(k) NO: K992920(TRADITIONAL)
ATTN: JONAS WILF PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 23-NOV-99
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS WRISTFIX SYSTEM
EBI, L.P. 510(k) NO: K993649(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 19-NOV-99
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNEFLASH & SYNEVIEW
ELA MEDICAL, INC. 510(k) NO: K990727(TRADITIONAL)
ATTN: CATHERINE G GOBLE PHONE NO : 612-519-9400
2950 XENIUM LANE NORTH SE DECISION MADE: 26-NOV-99
PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HICHEM ISE ELECTROLYTE REFERENCE
ELAN HOLDINGS, INC. 510(k) NO: K992842(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 26-NOV-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HICHEM ISE ELECTROLYTE BUFFER
ELAN HOLDINGS, INC. 510(k) NO: K992844(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 26-NOV-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENABLE ENDOSCOPIC BIPOLAR SCISSORS
ENABLE MEDICAL CORP. 510(k) NO: K992996(TRADITIONAL)
ATTN: MARK L FRIEDMAN PHONE NO : 513-755-7600
6345 CENTRE PARK DR. SE DECISION MADE: 24-NOV-99
WEST CHESTER, OH 45069-3863 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOBAR SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K992738(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 08-NOV-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
ENTIFIC MEDICAL SYSTEMS INC. 510(k) NO: K992872(TRADITIONAL)
ATTN: BESTY A BROWN PHONE NO : 847-677-8944
8944 TAMAROA TERRACE SE DECISION MADE: 24-NOV-99
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYTAC
ESPE DENTAL AG 510(k) NO: K992909(TRADITIONAL)
ATTN: ANDREAS PETERMAN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 24-NOV-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GA
ETHICON ENDO-SURGERY, INC. 510(k) NO: K992813(TRADITIONAL)
ATTN: TAMIMA ITANI PHONE NO : 513-483-8205
4545 CREEK RD. SE DECISION MADE: 18-NOV-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED A
EXACTECH, INC. 510(k) NO: K993082(TRADITIONAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 19-NOV-99
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLDLIGHTSOURCE PL3000
FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K993300(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 05-NOV-99
NEWTON, MA 02468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
FIBRA SONICS, INC. 510(k) NO: K993046(TRADITIONAL)
ATTN: ROBERT BROHM PHONE NO : 773-286-7377
5312 NORTH ELSTON AVE. SE DECISION MADE: 22-NOV-99
CHICAGO, IL 60630 510(k) STATEMENT
DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN METHADONE TEST, MOD
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K992325(TRADITIONAL)
ATTN: PERRY RUCKER PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 18-NOV-99
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN MORPHINE 2000 TEST,
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K992329(TRADITIONAL)
ATTN: PERRY RUCKER PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D SE DECISION MADE: 18-NOV-99
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: WHEELCHAIR (MANUAL, NOT ELECTRICAL)
FOSHAN MACHINERY & EQUIPMENT IMPOR510(k) NO: K992884(TRADITIONAL)
ATTN: DON W KANG PHONE NO : 201-947-9080
2414 2ND STREET SE DECISION MADE: 02-NOV-99
FORT LEE, NJ 07024 510(k) STATEMENT
DEVICE: SPECTRUM LIBRE WHEELCHAIR
FREEDOM DESIGNS, INC. 510(k) NO: K993640(TRADITIONAL)
ATTN: GINNY S MALOCO PHONE NO : 800-331-8551
2241 MADERA ROAD SE DECISION MADE: 16-NOV-99
SIMI VALLEY, CA 93065 510(k) STATEMENT
DEVICE: MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991786(TRADITIONAL)
ATTN: LAURA L MCCOMIS PHONE NO : 414-355-3790
8200 WEST TOWER AVE. SE DECISION MADE: 18-NOV-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSE CARDIOVASCULAR INFORMATION SYSTEM
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K992637(TRADITIONAL)
ATTN: LAURA L MCCOMIS PHONE NO : 414-362-2688
8200 WEST TOWER AVE. SE DECISION MADE: 03-NOV-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DASH 3000 PATIENT MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K992929(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 26-NOV-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC-LAB SYSTEM
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K992948(TRADITIONAL)
ATTN: MARIA VITUG FOUTS PHONE NO : 561-575-5000
8200 WEST TOWER AVE. SE DECISION MADE: 29-NOV-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K992746(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 09-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993364(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 05-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993365(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 05-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGEND CRF FLUORO AND RAD SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993665(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414 SE DECISION MADE: 12-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT PERFUSION OPTION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993791(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 24-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART VESSEL ANALYSIS (SMART VA) OPTION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993792(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 24-NOV-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASTLE SURGICAL LIGHT, MODEL 3000
GETINGE/CASTLE, INC. 510(k) NO: K993242(TRADITIONAL)
ATTN: PETER L KOSTE PHONE NO : 803-552-8652
7371 SPARTAN BLVD. EAST SE DECISION MADE: 08-NOV-99
NORTH CHARLESTON, SC 29418-8444 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELSONIC 2000
GREEN RIVER, INC. 510(k) NO: K990546(TRADITIONAL)
ATTN: CESAR CORAL PHONE NO : 954-733-4300
5101 N.W. 21ST AVE., SUITE 141 SE DECISION MADE: 05-NOV-99
FORT LAUDERDALE, FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEAD STYLET,MODELS 6505,6506,6507,6508
GUIDANT CORP. 510(k) NO: K992863(TRADITIONAL)
ATTN: SHERYL POGANSKI PHONE NO : 651-582-5110
4100 HAMLINE AVE., NORTH SE DECISION MADE: 12-NOV-99
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 100
GUIDANT CORP. 510(k) NO: K993588(SPECIAL)
ATTN: SANTA SUNDELL PHONE NO : 408-845-4278
3200 LAKESIDE DR. SE DECISION MADE: 17-NOV-99
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS
HAEMONETICS CORP. 510(k) NO: K993581(SPECIAL)
ATTN: ALICIA R LOPEZ PHONE NO : 781-356-9253
400 WOOD RD. SE DECISION MADE: 18-NOV-99
BRAINTREE, MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIT WIDGET
HAND BIOMECHANICS LAB, INC. 510(k) NO: K992970(TRADITIONAL)
ATTN: JOHN M AGEE PHONE NO : 916-920-0484
77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 08-NOV-99
SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTE
HARTALEGA SDN BHD 510(k) NO: K993722(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 03 634 2177
9 JLN KANAN,KEPONG GARDEN SE DECISION MADE: 23-NOV-99
INDUSTR ESTATE 510(k) STATEMENT
KUALA LUMPUR, 52100, MALAYSIA
DEVICE: GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROT
HARTALEGA SDN BHD 510(k) NO: K993725(TRADITIONAL)
ATTN: JUAN KAM HON PHONE NO : 03 634 2177
9 JLN KANAN,KEPONG GARDEN SE DECISION MADE: 23-NOV-99
INDUSTR ESTATE 510(k) STATEMENT
KUALA LUMPUR, 52100, MALAYSIA
DEVICE: HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
HEALTH HERO NETWORK, INC. 510(k) NO: K993128(TRADITIONAL)
ATTN: JOE SCHWOEBEL PHONE NO : 650-559-1000
2570 WEST EL CAMINO REAL SE DECISION MADE: 23-NOV-99
SUITE 111 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94040
DEVICE: RETIC-QUINOX
HEMATRONIX, INC. 510(k) NO: K993496(TRADITIONAL)
ATTN: JAMES D LAPICOLA PHONE NO : 707-746-7833
524 STONE RD. SE DECISION MADE: 30-NOV-99
BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP M2600A VIRIDIA TELEMETRY SYSTEM
HEWLETT-PACKARD CO. 510(k) NO: K993516(SPECIAL)
ATTN: DENISE HALEY PHONE NO : 978-687-1501
3000 MINUTEMAN ROAD, MS 0491 SE DECISION MADE: 08-NOV-99
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
HEWLETT-PACKARD GMBH 510(k) NO: K992674(ABBREVIATED)
ATTN: EGON PFEIL PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140 SE DECISION MADE: 08-NOV-99
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992287(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 16-NOV-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA SPINAL SYSTEM C-C ADAPTOR
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992792(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 16-NOV-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993352(SPECIAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-934-4375
59 ROUTE 17 SE DECISION MADE: 19-NOV-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS FEMORAL HEADS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993601(SPECIAL)
ATTN: NANCY J RIEDER PHONE NO : 201-507-7956
359 VETERANS BLVD. SE DECISION MADE: 16-NOV-99
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993603(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 19-NOV-99
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED LONG LENGTH GAMMA NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993670(SPECIAL)
ATTN: MARGARET CROWE PHONE NO : 201-507-6922
359 VETERANS BLVD. SE DECISION MADE: 16-NOV-99
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKRON ATP9 TRACTION MACHINE
HUNTLEIGH TECHNOLOGY, INC. 510(k) NO: K992733(TRADITIONAL)
ATTN: AUDREY WITKO PHONE NO : 732-446-2500
227 RTE 33 EAST SE DECISION MADE: 10-NOV-99
MANALAPAN, NJ 07726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-
IMATRON, INC. 510(k) NO: K992740(TRADITIONAL)
ATTN: J.A. CODUTO PHONE NO : 503-638-5500
389 OYSTER POINT BLVD. SE DECISION MADE: 09-NOV-99
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIV
IMCOR 510(k) NO: K992512(TRADITIONAL)
ATTN: ROBERT S URA PHONE NO : 612-942-2060
8000 WEST 78TH ST., SUITE 115 SE DECISION MADE: 01-NOV-99
EDINA, MN 55439 510(k) STATEMENT
DEVICE: STINGRAY DR, MODEL 1
INFIMED, INC. 510(k) NO: K992794(TRADITIONAL)
ATTN: RALPH FLATAU PHONE NO : 315-453-4545
121 METROPOLITAN DR. SE DECISION MADE: 09-NOV-99
LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
INNOVATIVE GLOVES CO; LTD 510(k) NO: K993221(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 442 8408
11 CHOTEVITTAYAKUL 3 ROAD SE DECISION MADE: 05-NOV-99
KHOHONG, HATYAI,SONGKHLA, THAILAND510(k) STATEMENT
DEVICE: INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
INNOVATIVE GLOVES CO; LTD 510(k) NO: K993222(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 442 8408
11 CHOTEVITTAYAKUL 3 ROAD SE DECISION MADE: 05-NOV-99
KHOHONG, HATYAI,SONGKHLA, THAILAND510(k) STATEMENT
DEVICE: INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
INNOVATIVE GLOVES CO; LTD 510(k) NO: K993325(TRADITIONAL)
ATTN: RAJEEV KUMAR SOOD PHONE NO : 667 442 8408
11 CHOTEVITTAYAKUL 3 ROAD SE DECISION MADE: 05-NOV-99
KHOHONG, HATYAI,SONGKHLA, THAILAND510(k) STATEMENT
DEVICE: IL TEST VON WILLEBRAND FACTOR
INSTRUMENTATION LABORATORY CO. 510(k) NO: K992704(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE SE DECISION MADE: 01-NOV-99
LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM PREMIER 3000
INSTRUMENTATION LABORATORY CO. 510(k) NO: K992834(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE SE DECISION MADE: 24-NOV-99
LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIRSCAN
INTELLIGENCE ARTIFICIELLE APPLICAT510(k) NO: K991473(TRADITIONAL)
ATTN: MARC J SCHEINESON PHONE NO : 202-414-9243
1301 K STREET N.W. SE DECISION MADE: 23-NOV-99
SUITE 1100- EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: IBC VENT VALVE, MODEL 1400
INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K992964(TRADITIONAL)
ATTN: H. DAVID SHOCKLET, JR PHONE NO : 512-326-3244
4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 19-NOV-99
SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744
DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
JDA INTL., INC. 510(k) NO: K993247(TRADITIONAL)
ATTN: KEIDY GU PHONE NO : 909-923-8318
2919 EAST PHILADELPHIA ST. SE DECISION MADE: 05-NOV-99
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: OPC LOW WEAR OPAQUE PORCELAIN
JENERIC/PENTRON, INC. 510(k) NO: K993249(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 29-NOV-99
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
JUSTEC MEDICAL PRODUCTS, INC. 510(k) NO: K990229(TRADITIONAL)
ATTN: JEFFREY L ROTHMAN PHONE NO : 516-563-1851
1724 CHURCH ST. SE DECISION MADE: 04-NOV-99
HOLBROOK, NY 11741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
KAMIYA BIOMEDICAL CO. 510(k) NO: K992976(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 01-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY IGA
KAMIYA BIOMEDICAL CO. 510(k) NO: K993213(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 23-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY IGG
KAMIYA BIOMEDICAL CO. 510(k) NO: K993281(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 09-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY IGM
KAMIYA BIOMEDICAL CO. 510(k) NO: K993323(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 30-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY C3
KAMIYA BIOMEDICAL CO. 510(k) NO: K993437(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 24-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY ALPHA-1 AG
KAMIYA BIOMEDICAL CO. 510(k) NO: K993441(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 24-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY ALPHA-1 AT
KAMIYA BIOMEDICAL CO. 510(k) NO: K993444(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 24-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY HAPTOGLOBIN
KAMIYA BIOMEDICAL CO. 510(k) NO: K993480(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 24-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY C4
KAMIYA BIOMEDICAL CO. 510(k) NO: K993481(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 29-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY TRANSFERRIN
KAMIYA BIOMEDICAL CO. 510(k) NO: K993537(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 30-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: K-ASSAY APO A1/B CALIBRATOR SET
KAMIYA BIOMEDICAL CO. 510(k) NO: K993606(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 26-NOV-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: KSEA DE LA PLAZA BLEPHAROPLASTY SET
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K991592(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 02-NOV-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K993540(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 22-NOV-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
KPS & ASSOC., INC. 510(k) NO: K990475(TRADITIONAL)
ATTN: KRISHNA P SINHA PHONE NO : 801-359-4631
851 EAST NORTHCREST DR. SE DECISION MADE: 18-NOV-99
SALT LAKE CITY, UT 84103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
LABORIE MEDICAL TECH CORP. 510(k) NO: K993721(ABBREVIATED)
ATTN: DALE COLEMAN PHONE NO : 802-878-1110
310 HURRICANE LANE #2 SE DECISION MADE: 29-NOV-99
WILLISTON, VT 05495 510(k) STATEMENT
DEVICE: LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR D
LAMDA POLYTECH LTD. 510(k) NO: K991015(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 02-NOV-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMI
LASEREX SYSTEMS 510(k) NO: K992824(TRADITIONAL)
ATTN: KEITH DEGENHARDT PHONE NO : 088 223 6644
258 HALIFAX ST. SE DECISION MADE: 17-NOV-99
ADELAIDE, S.A., AUSTRALIA 5000 510(k) STATEMENT
DEVICE: QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES,
LATEXX PARTNERS BHD. 510(k) NO: K992924(TRADITIONAL)
ATTN: LIM CHONG ENG PHONE NO : 605 891 5555
PT. 5054, KAMUNTING IND ESTATE SE DECISION MADE: 05-NOV-99
P.O. BOX 9 510(k) SUMMARY AVAILABLE FROM FDA
KAMUNTING, PERAK, MALAYSIA 34600
DEVICE: LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
LIGHT DIAGNOSTICS 510(k) NO: K991880(TRADITIONAL)
ATTN: CINDY PENNY PHONE NO : 909-676-8080
28835 SINGLE OAK DR. SE DECISION MADE: 09-NOV-99
TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STICK BIPOLAR FORCEPS
LINK TECHNOLOGY, INC. 510(k) NO: K992931(TRADITIONAL)
ATTN: KEVIN MORNINGSTAR PHONE NO : 303-697-8198
P.O. BOX 219 SE DECISION MADE: 17-NOV-99
INDIAN HILLS, CO 80454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE BULLET SUTURE ANCHOR
LINVATEC CORP. 510(k) NO: K991024(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 16-NOV-99
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO-PIN MEMBRANE FIXATION PIN
LUITPOLD PHARMACEUTICALS, INC. 510(k) NO: K990537(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 19-NOV-99
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
MASIMO CORP. 510(k) NO: K993555(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 19-NOV-99
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI BOND NON-PRECIOUS CERAMIC ALLOY
MATECH, INC. 510(k) NO: K992881(TRADITIONAL)
ATTN: PAUL L SAXTON PHONE NO : 818-367-2472
13010 SAN FERNANDO RD. SE DECISION MADE: 19-NOV-99
SYLMAR, CA 91342 510(k) STATEMENT
DEVICE: MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
MEDARTIS AG 510(k) NO: K992682(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
1601 TRAPELO ROAD SE DECISION MADE: 24-NOV-99
RESERVOIR PLACE 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: MODUS 2.5 MANDIBULAR TRAUMA SET
MEDARTIS AG 510(k) NO: K992683(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
1601 TRAPELO ROAD SE DECISION MADE: 24-NOV-99
RESERVOIR PLACE 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: ULTRA-CBX
MEDCANICA, INC. 510(k) NO: K991486(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 05-NOV-99
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIB
MEDICA, INC. 510(k) NO: K993034(TRADITIONAL)
ATTN: RHODORA CHAPOCO PHONE NO : 760-634-5440
336 ENCINITAS BLVD., SUITE 200 SE DECISION MADE: 01-NOV-99
ENCINITAS, CA 92024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K992829(TRADITIONAL)
ATTN: MARY D THORSNESS PHONE NO : 805-987-7891
542 FLYNN RD. SE DECISION MADE: 22-NOV-99
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K993546(TRADITIONAL)
ATTN: SCOT KINGHORN PHONE NO : 805-987-7891
LINCOLN TECHNOLOGY PARK SE DECISION MADE: 30-NOV-99
542 FLYNN RD. 510(k) STATEMENT
CAMARILLO, CA 93012
DEVICE: MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
MEDICAL COMPONENTS, INC. 510(k) NO: K991320(TRADITIONAL)
ATTN: JEANNE M CUSH PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 10-NOV-99
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PBN DILATORS
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K990808(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 S.W. 47TH AVE. SE DECISION MADE: 26-NOV-99
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMEX
MEDICAL SYSTEMS GROUP 510(k) NO: K993740(SPECIAL)
ATTN: JEFFREY N MOELLER PHONE NO : 847-288-7000
11550 WEST KING STREET SE DECISION MADE: 26-NOV-99
FRANKLIN PARK, IL 60131 510(k) STATEMENT
DEVICE: RAPICURE 200 (CURING AND WHITENING LIGHT)
MEDIPHOTONIX, LC 510(k) NO: K993223(TRADITIONAL)
ATTN: ROBERT MCCLANE PHONE NO : 801-363-4418
484 H STREET SE DECISION MADE: 01-NOV-99
SALT LAKE CITY, UT 84103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K993763(SPECIAL)
ATTN: DOUGLAS F ORR PHONE NO : 203-438-5588
109 DANBURY ROAD SE DECISION MADE: 26-NOV-99
RIDGEFIELD, CT 06877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K993765(SPECIAL)
ATTN: DOUGLAS F ORR PHONE NO : 203-438-5588
109 DANBURY ROAD SE DECISION MADE: 26-NOV-99
RIDGEFIELD, CT 06877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
MEDISON AMERICA, INC. 510(k) NO: K993517(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 925-463-1830
6616 OWENS DR. SE DECISION MADE: 02-NOV-99
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD ENVISION CT INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K993728(SPECIAL)
ATTN: JAN E DOBSCHA PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 26-NOV-99
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATI
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K992713(TRADITIONAL)
ATTN: ANN-CHRISTINE JONSSON PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 10-NOV-99
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MP-3 POWER BASE CHAIR
MERITS HEALTH PRODUCTS., INC. 510(k) NO: K993032(TRADITIONAL)
ATTN: WINSTON ANDERSON PHONE NO : 800-963-7487
P.O. BOX 150356 SE DECISION MADE: 05-NOV-99
CAPE CORAL, FL 33915 510(k) STATEMENT
DEVICE: OSTEOMARK NTX POC
METRIKA, INC. 510(k) NO: K992997(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 408-524-2255
510 OAKMEAD PARKWAY SE DECISION MADE: 09-NOV-99
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: MED-4000
MICRO CURRENT TECHNOLOGY, INC. 510(k) NO: K993823(TRADITIONAL)
ATTN: JAMES Y SUZUKI PHONE NO : 800-976-2544
4822 CALIFORNIA AVE., S.W., SE DECISION MADE: 19-NOV-99
SUITE 201 510(k) STATEMENT
SEATTLE, WA 98116
DEVICE: MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
MICROMEDICS, INC. 510(k) NO: K993234(TRADITIONAL)
ATTN: CHARLES GROTE PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR., SE DECISION MADE: 10-NOV-99
#150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
MINIMED TECHNOLOGIES, INC. 510(k) NO: K993012(TRADITIONAL)
ATTN: JENNIFER LYONS PHONE NO : 818-362-5958
12744 SAN FERNANDO RD. SE DECISION MADE: 15-NOV-99
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURE BOND
MIRADENT DISTRIBUTING CO., LLC 510(k) NO: K993013(TRADITIONAL)
ATTN: BERNARD SESSMAN PHONE NO : 973-267-5632
764 SPEEWELL AVE., SUITE 4 SE DECISION MADE: 29-NOV-99
MORRIS PLAINS, NJ 07950 510(k) STATEMENT
DEVICE: MITEK MINI ANCHOR
MITEK PRODUCTS 510(k) NO: K992623(TRADITIONAL)
ATTN: PAULA E BULGER PHONE NO : 781-251-2746
60 GLACIER DR. SE DECISION MADE: 02-NOV-99
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRW WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993477(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 01-NOV-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: KAC-300 KNEE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993719(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 26-NOV-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: QSC-300 SHOULDER ARRAY COILS
MRI DEVICES CORP. 510(k) NO: K993780(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 26-NOV-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K990177(TRADITIONAL)
ATTN: CHERYL ROSENBERG PHONE NO : 612-694-3638
2800 NORTHWEST BLVD. SE DECISION MADE: 18-NOV-99
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K993637(SPECIAL)
ATTN: DAVID A.C. GREEN PHONE NO : 760-603-5978
2200 FARADAY AVE. SE DECISION MADE: 24-NOV-99
CARLSBAD, CA 92008-7208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAVO MULTI-MODALITY SYSTEM
NICOLET BIOMEDICAL, INC. 510(k) NO: K991054(TRADITIONAL)
ATTN: DOUGLAS E PFRANG PHONE NO : 608-273-5000
5225 VERONA RD. SE DECISION MADE: 03-NOV-99
MADISON, WI 53711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMORPHOUS DIAMOND COATED SCREW
NOBEL BIOCARE USA, INC. 510(k) NO: K992538(TRADITIONAL)
ATTN: KIM RENDON PHONE NO : 714-282-4800
22895 EAST PARK DR. SE DECISION MADE: 23-NOV-99
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
NORLAND MEDICAL SYSTEMS, INC. 510(k) NO: K992125(TRADITIONAL)
ATTN: TERRY SCHWALENBERG PHONE NO : 920-563-8456
W-6340 HACKBARTH RD. SE DECISION MADE: 22-NOV-99
FORT ATKINSON, WI 53538-8999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P10 SPECIAL
NORTH AMERICAN ALLOYS, INC. 510(k) NO: K993344(TRADITIONAL)
ATTN: KATHLEEN CALERO PHONE NO : 630-980-5618
225 BRENTWOOD CT. SE DECISION MADE: 15-NOV-99
BLOOMINGDALE, IL 60108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON "F") UV BLOCKING
OCULAR SCIENCES, INC. 510(k) NO: K992264(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 24-NOV-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY
OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K992843(TRADITIONAL)
ATTN: KENNETH B MILLER PHONE NO : 513-561-2241
4900 CHARLEMAR DR. SE DECISION MADE: 02-NOV-99
CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
OHMEDA MEDICAL 510(k) NO: K993712(SPECIAL)
ATTN: ALBERTO F PROFUMO PHONE NO : 410-381-4004
9065 GUILFORD RD. SE DECISION MADE: 09-NOV-99
COLUMBIA, MD 21046-1801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
OLSON MEDICAL SALES, INC. 510(k) NO: K992906(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
2101 COTTONTAIL LANE SE DECISION MADE: 10-NOV-99
SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS NA-10J-KB ASPIRATION NEEDLE
OLYMPUS AMERICA, INC. 510(k) NO: K991672(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 03-NOV-99
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM
OMNIGRACE (THAILAND) LTD. 510(k) NO: K993479(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641 MOO 5 KANCHANAWANIT RD. SE DECISION MADE: 19-NOV-99
TAMBON BANPRU 510(k) STATEMENT
HATYAI, SONGKHLA, THAILAND 90250
DEVICE: OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYM
OMNIGRACE LTD. 510(k) NO: K993050(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878
7815 VANDERBILT DRIVE NW SE DECISION MADE: 09-NOV-99
NORTH CANTON, OH 44720 510(k) STATEMENT
DEVICE: OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED W
OMNIGRACE LTD. 510(k) NO: K993419(TRADITIONAL)
ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878
7815 VANDERBILT DRIVE NW SE DECISION MADE: 19-NOV-99
NORTH CANTON, OH 44720 510(k) STATEMENT
DEVICE: I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTE
OPHTHALMIC CONSULTANTS, INC. 510(k) NO: K990292(TRADITIONAL)
ATTN: JOHN E LINCOLN PHONE NO : 435-882-4655
65 N. MAIN, SUITE 101 SE DECISION MADE: 19-NOV-99
PO BOX 154 510(k) SUMMARY AVAILABLE FROM FDA
TOOELE, UT 84074
DEVICE: STAR TEMPORARY WOUND COVER
OSTEOGENICS, INC. 510(k) NO: K983753(TRADITIONAL)
ATTN: MICHAEL DEUTSCH PHONE NO : 414-539-3564
7781 LAKEVIEW DRIVE SE DECISION MADE: 18-NOV-99
BURLINGTON, WI 53105 510(k) STATEMENT
DEVICE: VERSALOK LOW BACK FIXATION SYSTEM
OSTEOTECH, INC. 510(k) NO: K992885(TRADITIONAL)
ATTN: JING ZHANG PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 19-NOV-99
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOJET 2 (NON-FIXED NEEDLE TYPE)
OWEN MUMFORD USA,INC. 510(k) NO: K993385(TRADITIONAL)
ATTN: ROBERT SHAW PHONE NO : 770-425-5138
849 PICKENS INDUSTRIAL DR. SE DECISION MADE: 10-NOV-99
SUITE 14 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30062-3165
DEVICE: SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
P.T. MAJA AGUNG LATEXINDO 510(k) NO: K992752(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 626-913-1798
889 SOUTH AZUSA AVENUE SE DECISION MADE: 05-NOV-99
INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL
PALADIN MEDICAL, INC. 510(k) NO: K993306(SPECIAL)
ATTN: ELAINE DUNCAN, M.S.M.E., RAPHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 03-NOV-99
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE GLOVES (POLYMER COATED)
PAN-CENTURY RUBBER PRODUCTS SDN. B510(k) NO: K993183(TRADITIONAL)
ATTN: H.R.K MURTHY PHONE NO : 600 725 18551
LOT 230, JALAN TIMAH 2, SE DECISION MADE: 19-NOV-99
PASIR GUDANG INDUSTRIAL ESTATE 510(k) STATEMENT
PASIR GUDANG, JOHOR, MALAYSIA 81700
DEVICE: PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
PASCO LABORATORIES, INC. 510(k) NO: K992717(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 02-NOV-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFA
PASCO LABORATORIES, INC. 510(k) NO: K992726(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 03-NOV-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, CEFDINIR
PASCO LABORATORIES, INC. 510(k) NO: K992853(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 04-NOV-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
PERRY BAROMEDICAL CORP. 510(k) NO: K990927(TRADITIONAL)
ATTN: JAMES P DODSON PHONE NO : 561-840-0395
3660 INTERSTATE PARKWAY SE DECISION MADE: 12-NOV-99
RIVERA BEACH, FL 33404 510(k) STATEMENT
DEVICE: AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
PHAMATECH 510(k) NO: K993141(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 08-NOV-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
PHARMACIA & UPJOHN CO. 510(k) NO: K993108(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-734-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 12-NOV-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA RECOMBI ANA PROFILE
PHARMACIA & UPJOHN CO. 510(k) NO: K993109(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 12-NOV-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA RNP ANTIBODIES
PHARMACIA & UPJOHN CO. 510(k) NO: K993589(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 26-NOV-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLAR CHIN IMPLANT
PILLAR SURGICAL 510(k) NO: K992239(TRADITIONAL)
ATTN: ROB FRITZENKOTTER PHONE NO : 619-295-6511
PO BOX 8141 SE DECISION MADE: 22-NOV-99
LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLAR MALAR IMPLANT
PILLAR SURGICAL 510(k) NO: K992240(TRADITIONAL)
ATTN: ROB FRITZENKOTTER PHONE NO : 619-295-6511
PO BOX 8141 SE DECISION MADE: 22-NOV-99
LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
PILLAR SURGICAL 510(k) NO: K992242(TRADITIONAL)
ATTN: RPB FRITZENKOTTER PHONE NO : 619-295-6511
PO BOX 8141 SE DECISION MADE: 22-NOV-99
LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER SILICOAT STERNAL CABLE
PIONEER LABORATORIES, INC. 510(k) NO: K993286(SPECIAL)
ATTN: AMY H MIMMAERTS PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 23-NOV-99
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZFLOW MAX, MODEL 1007
PIPER MEDICAL PRODUCTS 510(k) NO: K993558(TRADITIONAL)
ATTN: SAMUEL DAVID PIPER PHONE NO : 916-375-0112
4007 SEAPORT BLVD. SE DECISION MADE: 12-NOV-99
WEST SACRAMENTO, CA 95691 510(k) STATEMENT
DEVICE: E Z CHAIR
PREMIER DESIGNS 510(k) NO: K993298(TRADITIONAL)
ATTN: CHRIS BERRYHILL PHONE NO : 559-277-3525
4834 W. JACQUELYN SE DECISION MADE: 16-NOV-99
SUITE 101 510(k) STATEMENT
FRESNO, CA 93722
DEVICE: AURORA SL
PREMIER LASER SYSTEMS 510(k) NO: K993285(TRADITIONAL)
ATTN: BETH A ROBERTS PHONE NO : 317-585-8160
3 MORGAN SE DECISION MADE: 18-NOV-99
IRVINE, CA 92718 510(k) STATEMENT
DEVICE: PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
PRIMUS CORP. 510(k) NO: K992921(TRADITIONAL)
ATTN: JIMMIE K NOFFSINGER PHONE NO : 816-523-7491
P.O. BOX 22599 SE DECISION MADE: 12-NOV-99
KANSAS CITY, MO 64113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
PROSTHETIC SOFT LENS CORP. 510(k) NO: K992950(TRADITIONAL)
ATTN: WILLIAM HOFFMAN PHONE NO : 303-789-0933
2890 SOUTH TEJON ST. SE DECISION MADE: 18-NOV-99
ENGLEWOOD, CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMP
PURITAN BENNETT CORP. 510(k) NO: K993071(SPECIAL)
ATTN: DELTON WEST PHONE NO : 760-603-5300
2200 FARADAY AVE. SE DECISION MADE: 24-NOV-99
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTECH CK-MB ASSAY
QUANTECH LTD. 510(k) NO: K984433(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 01-NOV-99
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIASURE CARDIAC MARKERS CONTROL
QUANTIMETRIX CORP. 510(k) NO: K993723(TRADITIONAL)
ATTN: EVY K JOHNSON PHONE NO : 310-536-0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 23-NOV-99
REDONDO BEACH, CA 90278-1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERAQUEST EB NA IGG
QUEST INTL., INC. 510(k) NO: K991975(TRADITIONAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERRACE SE DECISION MADE: 02-NOV-99
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D HGB/GLC WHOLE BLOOD CONTROL
R & D SYSTEMS, INC. 510(k) NO: K993321(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 12-NOV-99
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL 735 ANALYZER
RADIOMETER AMERICA, INC. 510(k) NO: K991417(TRADITIONAL)
ATTN: VINCE SIGMUND PHONE NO : 800-736-0600
810 SHARON DR. SE DECISION MADE: 24-NOV-99
WESTLAKE, OH 44145-1598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FS 1000 KNEE SYSTEM
RENAISSANCE INSTRUMENTS, LLC 510(k) NO: K991052(TRADITIONAL)
ATTN: KENT M SAMUELSON PHONE NO : 801-363-5980
370 NINTH AVE., SUITE 205 SE DECISION MADE: 10-NOV-99
SALT LAKE CITY, UT 84103 510(k) STATEMENT
DEVICE: RESPIRONICS TOTAL FACE MASK
RESPIRONICS, INC. 510(k) NO: K992969(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DR. SE DECISION MADE: 10-NOV-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VID
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991906(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 23-NOV-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR C
ROCHE DIAGNOSTICS CORP. 510(k) NO: K992492(TRADITIONAL)
ATTN: LUANN OCHS PHONE NO : 317-845-2000
9115 HAGUE RD. SE DECISION MADE: 02-NOV-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE COBAS INTEGRA OPIATES 300/2000
ROCHE DIAGNOSTICS CORP. 510(k) NO: K992890(TRADITIONAL)
ATTN: LISA GERARD PHONE NO : 317-576-3362
9115 HAGUE RD. SE DECISION MADE: 23-NOV-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
ROCHE DIAGNOSTICS CORP. 510(k) NO: K992900(TRADITIONAL)
ATTN: PRICILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 24-NOV-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K993360(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 24-NOV-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PARATHYROID HORMONE CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K993642(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 30-NOV-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201
ROCKY MOUNTAIN RESEARCH, INC. 510(k) NO: K992857(TRADITIONAL)
ATTN: ROBERT W GRIFFITHS PHONE NO : 801-359-6060
825 NORTH 300 WEST, # NE 500 SE DECISION MADE: 10-NOV-99
SALT LAKE CITY, UT 84103 510(k) STATEMENT
DEVICE: TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
RUPIANI MEDICAL 510(k) NO: K992310(TRADITIONAL)
ATTN: JEAN-MARIE MANGENOT PHONE NO : 011 334 72375724
98 RUE ALEXANDRE DUMAS SE DECISION MADE: 02-NOV-99
VAULX EN VELIN, FRANCE 69120 510(k) STATEMENT
DEVICE: ISOBAR SEMI-RIGID SPINAL SYSTEM
SCIENT'X 510(k) NO: K991326(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 08-NOV-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBOCEM ZINC POLYCARBOXYLATE CEMENT
SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K993324(TRADITIONAL)
ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922
3221 PRODUCER WAY SE DECISION MADE: 09-NOV-99
POMONA, CA 91768 510(k) STATEMENT
DEVICE: 3D1 MICROPOSITIONING HEADSTAGE
SCIENTIFIC TOOLS, INC. 510(k) NO: K993501(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 22-NOV-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AN
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K993133(TRADITIONAL)
ATTN: CHAN CHIN HONG PHONE NO : 605 322 3200
LT 72706 KAWASAN PERINDUSTRIAN SE DECISION MADE: 17-NOV-99
BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, PERAK, MALAYSIA 31500
DEVICE: CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLU
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K993134(TRADITIONAL)
ATTN: CHAN CHIN HONG PHONE NO : 605 322 3200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 17-NOV-99
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K993326(TRADITIONAL)
ATTN: CHAN CHIN HONG PHONE NO : 605 322 3200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 17-NOV-99
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: MILLENNIUM INFANT VENTILATOR
SECHRIST INDUSTRIES, INC. 510(k) NO: K993167(SPECIAL)
ATTN: GREG GODFREY PHONE NO : 714-579-8318
4225 EAST LA PALMA SE DECISION MADE: 10-NOV-99
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
SELFCARE, INC. 510(k) NO: K993632(SPECIAL)
ATTN: CAROL ADILETTO PHONE NO : 781-647-3900
200 PROSPECT ST. SE DECISION MADE: 12-NOV-99
WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
SERACARE TECHNOLOGY 510(k) NO: K992770(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
2170 WOODWARD ST. SE DECISION MADE: 12-NOV-99
AUSTIN, TX 78744-1832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
SERACARE TECHNOLOGY 510(k) NO: K993715(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
2170 WOODWARD ST. SE DECISION MADE: 16-NOV-99
AUSTIN, TX 78744-1832 510(k) STATEMENT
DEVICE: CIDEX OPA SOLUTION TEST STRIP
SERIM RESEARCH CORP. 510(k) NO: K992341(TRADITIONAL)
ATTN: JAMES E CHRISTNER PHONE NO : 219-264-3440
23565 REEDY DRIVE SE DECISION MADE: 23-NOV-99
P.O. BOX 4002 510(k) SUMMARY AVAILABLE FROM FDA
ELKHART, IN 46514
DEVICE: DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K993049(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 86 21 5781-42132
259 YUSHU RD., SE DECISION MADE: 19-NOV-99
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA
DEVICE: SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K984203(TRADITIONAL)
ATTN: ROBERT MORTON PHONE NO : 925-210-0715
1106 CHILTERN DRIVE SE DECISION MADE: 01-NOV-99
WALNUT CREEK, CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992862(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
13945 MAGNOLIA AVE SE DECISION MADE: 29-NOV-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K992797(TRADITIONAL)
ATTN: KAREN ABELL PHONE NO : 909-548-4828
12390 EAST END AVE SE DECISION MADE: 05-NOV-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AX WORKSTATION DR-VIEWER SOFTWARE OPTION
SIEMENS CORP. 510(k) NO: K992925(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-3950
186 WOOD AVE., SOUTH SE DECISION MADE: 23-NOV-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990826(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 732-321-4622
186 WOOD AVENUE SOUTH SE DECISION MADE: 01-NOV-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS FIO2 SENSOR
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991884(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 03-NOV-99
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URF DIGITAL - OT
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992660(TRADITIONAL)
ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950
186 WOOD AVENUE SOUTH SE DECISION MADE: 05-NOV-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E.CAM COMPUTER
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992731(TRADITIONAL)
ATTN: ROBERT W CALLAHAN PHONE NO : 847-304-7516
2501 NORTH BARRINGTON RD. SE DECISION MADE: 10-NOV-99
HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMUS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K993425(SPECIAL)
ATTN: KATHRYN B DODD PHONE NO : 925-602-8027
4040 NELSON AVE. SE DECISION MADE: 26-NOV-99
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAY-LINK
SILICON-UND COMPOSITE SPEZIALITATE510(k) NO: K992001(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 041 218 619
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 02-NOV-99
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
SIMS DELTEC, INC. 510(k) NO: K992697(TRADITIONAL)
ATTN: LISA J STONE PHONE NO : 651-633-2556
1265 GREY FOX RD. SE DECISION MADE: 18-NOV-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABRE
SLE LIMITED 510(k) NO: K993177(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
PO BOX 12038 SE DECISION MADE: 16-NOV-99
LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSE
SMITH & NEPHEW ENT. 510(k) NO: K992994(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 23-NOV-99
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCI FIXATION SCREWS (WITH ASSORTED SIZES)
SMITH & NEPHEW, INC. 510(k) NO: K992945(TRADITIONAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-261-3770
130 FORBES BLVD. SE DECISION MADE: 18-NOV-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRAT
SORIN BIOMEDICAL, INC. 510(k) NO: K990103(TRADITIONAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
17600 GILLETTE AVE. SE DECISION MADE: 05-NOV-99
IRVINE, CA 92614-5751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRANETICS 0.014" SUPPORT CATHETER, MODEL 518-016, SPECTRANET
SPECTRANETICS CORP. 510(k) NO: K991059(TRADITIONAL)
ATTN: MICHAEL J QUINN PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 16-NOV-99
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIL, NITRILE EXAMINATION GLOVE - POWDERED
SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K993347(TRADITIONAL)
ATTN: N PARAMASIVAN PHONE NO : 914 562 33091
PIONEER MANIKANDAN BLDG. SE DECISION MADE: 19-NOV-99
VADASERY, NAGERCOIL, TN, INDIA 629510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K993348(TRADITIONAL)
ATTN: N PARAMASIVAN PHONE NO : 914 652 33091
PIONEER MANIKANDAN BLDG. SE DECISION MADE: 19-NOV-99
VADASERY, NAGERCOIL, TN, INDIA 629510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIL, SURGEON'S GLOVE - POWDER FREE
SRI ANUSHAM RUBBER INDUSTRIES PVT.510(k) NO: K993349(TRADITIONAL)
ATTN: N PARAMASIVAN PHONE NO : 914 456 233091
PIONEER MANIKANDAN BLDG. SE DECISION MADE: 23-NOV-99
VADASERY, NAGERCOIL, TN, INDIA 629510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
SRI JOHANI SDN. BHD. 510(k) NO: K993458(TRADITIONAL)
ATTN: LIM LEE AIK PHONE NO : 603 961 1211
LOT PT 7178, BALAKONG N/V, SE DECISION MADE: 10-NOV-99
SERI KEMBANGAN 510(k) STATEMENT
SELANGOR, MALAYSIA 43300
DEVICE: STAK-CHEX PLUS RETICS
STRECK LABORATORIES, INC. 510(k) NO: K992887(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-691-7465
14124 INDUSTRIAL RD. SE DECISION MADE: 22-NOV-99
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD-CHEX CD 34
STRECK LABORATORIES, INC. 510(k) NO: K993126(TRADITIONAL)
ATTN: HAL SORNSON PHONE NO : 402-691-7458
14124 INDUSTRIAL RD. SE DECISION MADE: 26-NOV-99
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARA TECH PLUS RETICS
STRECK LABORATORIES, INC. 510(k) NO: K993825(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-691-7465
14124 INDUSTRIAL RD. SE DECISION MADE: 30-NOV-99
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
STRYKER CORP. 510(k) NO: K993583(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVENUE SE DECISION MADE: 10-NOV-99
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K993061(TRADITIONAL)
ATTN: KRISTEN R KELLEY PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 19-NOV-99
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
SULZER MEDICA 510(k) NO: K992832(TRADITIONAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-435-3407
1300 EAST ANDERSON LANE SE DECISION MADE: 19-NOV-99
AUSTIN, TX 78752-1793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILHOUETTE SPINAL FIXATION SYSTEM
SULZER SPINE-TECH 510(k) NO: K993067(SPECIAL)
ATTN: JANELL A COLLEY PHONE NO : 612-832-5600
7375 BUSH LAKE RD. SE DECISION MADE: 16-NOV-99
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS 5 LITER OXYGEN CONCENTRATOR
SUNRISE MEDICAL HHG, INC. 510(k) NO: K991722(TRADITIONAL)
ATTN: GREG CLITES PHONE NO : 814-443-7441
100 DEVILBISS DR. SE DECISION MADE: 03-NOV-99
P.O. BOX 635 510(k) SUMMARY AVAILABLE FROM FDA
SOMERSET, PA 15501
DEVICE: OXY-GLIDE ROOT CANAL CLEANSER & LUB.
SUPER GLIDE, INC. 510(k) NO: K992919(TRADITIONAL)
ATTN: VICTOR L RATKUS PHONE NO : 802-864-0461
227 COLCHESTER AVE. SE DECISION MADE: 19-NOV-99
BURLINGTON, VT 05401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METRX SYSTEM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K993021(TRADITIONAL)
ATTN: ROGER N WHITE PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 10-NOV-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM HARTSHILL SYSTEM
SURGICRAFT LTD. 510(k) NO: K991662(TRADITIONAL)
ATTN: SIMON FITZER PHONE NO : 015 276 6331
FISHING LINE RD. SE DECISION MADE: 08-NOV-99
REDDITCH, WORCS., UNITED KINGDOM B510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RICROKERATOME BLADE
SURGISTAR, INC. 510(k) NO: K992978(TRADITIONAL)
ATTN: JONATHAN WOODWARD PHONE NO : 760-431-7400
6068 CORTE DEL CEDRO SE DECISION MADE: 16-NOV-99
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CERCLAGE POSITIONING PIN
SYNTHES (USA) 510(k) NO: K992891(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 02-NOV-99
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
SYSMEX CORP. 510(k) NO: K992875(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-726-3675
ONE WILDLIFE WAY SE DECISION MADE: 09-NOV-99
LONG GROVE, IL 60047-9596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA TRAC, MODEL Z100
TEFTEC CORP. 510(k) NO: K993160(SPECIAL)
ATTN: THOMAS E FINCH, III PHONE NO : 830-885-7588
6929 OLD SPRING BRANCH RD. SE DECISION MADE: 18-NOV-99
SPRING BRANCH, TX 78070-5104 510(k) STATEMENT
DEVICE: TED 60T OXYGEN ANALYZER
TELEDYNE ELECTRONIC TECHNOLOGIES 510(k) NO: K990457(TRADITIONAL)
ATTN: RAY KHAJAVI PHONE NO : 626-934-1502
16830 CHESTNUT STREET SE DECISION MADE: 09-NOV-99
CITY OF INDUSTRY, CA 510(k) STATEMENT
DEVICE: TERATECH, MODEL 2000 IMAGING IMAGING
TERATECH CORPORATION 510(k) NO: K992505(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 10-NOV-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMEAIRE
THAYER MEDICAL CORP. 510(k) NO: K992722(TRADITIONAL)
ATTN: DAVID T SLADEK PHONE NO : 520-790-5393
4575 SOUTH PALO VERDE RD., SE DECISION MADE: 10-NOV-99
SUITE 337 510(k) STATEMENT
TUCSON, AZ 85714
DEVICE: IGA MININEPH ANTISERUM
THE BINDING SITE, LTD. 510(k) NO: K981786(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 24-NOV-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
THE BINDING SITE, LTD. 510(k) NO: K981914(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 26-NOV-99
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: DECAP
THE KIPP GROUP 510(k) NO: K993147(TRADITIONAL)
ATTN: GARY WERSCHMIDT PHONE NO : 909-390-9080
930 WANAMAKER AVE. SE DECISION MADE: 02-NOV-99
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: ECHO SCAN, EASY SCAN
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K993394(SPECIAL)
ATTN: FLORIAN EISENBERGER PHONE NO : 004 989 32175830
EDISONSTRASSE 6 SE DECISION MADE: 05-NOV-99
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO VIEW, EASY VIEW, OMNI VIEW
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K993398(SPECIAL)
ATTN: FLORIAN EISENBERGER PHONE NO : 498 932 175830
EDISONSTRASSE 6 SE DECISION MADE: 05-NOV-99
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K992886(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 09-NOV-99
TUSTIN, CA 92781-2068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACRA LP(A) ENZYME IMMUNOASSAY KIT
TRINITY BIOTECH USA 510(k) NO: K992665(TRADITIONAL)
ATTN: WAYNE A KVETKOSKY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-99
JAMESTOWN, NY 14702-1059 510(k) STATEMENT
DEVICE: UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER A
UNIMED SURGICAL PRODUCTS, INC. 510(k) NO: K993647(SPECIAL)
ATTN: LEE ALEXANDER PHONE NO : 727-546-1900
10401 BELCHER RD. SE DECISION MADE: 16-NOV-99
LARGO, FL 33777 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUG 'N VIEW 3D, VERSION 1.0
VOXAR LIMITED 510(k) NO: K992654(TRADITIONAL)
ATTN: ROB MACKEAN PHONE NO : 44 131 4724792
BONNINGTON BOND SE DECISION MADE: 05-NOV-99
2 ANDERSON PLACE 510(k) SUMMARY AVAILABLE FROM FDA
EDINBURGH, UNITED KINGDOM
DEVICE: WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K993162(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 12-NOV-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO BILIRUBIN CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K993219(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 09-NOV-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE TRIGLYCERIDE TEST
WAKO CHEMICALS, USA, INC. 510(k) NO: K993466(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 09-NOV-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO L-TYPE UA F TEST
WAKO CHEMICALS, USA, INC. 510(k) NO: K993469(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 09-NOV-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ DISTRACTION SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K992952(TRADITIONAL)
ATTN: DIANA PRESTON PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 19-NOV-99
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ SMALL FRAGMENT SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K992961(TRADITIONAL)
ATTN: DIANA PRESTON PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 08-NOV-99
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992678(TRADITIONAL)
ATTN: CLAUDE COTTET PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 17-NOV-99
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: FACE-2-FACE CPR PROTECTION SHIELD
WHITELINE PLASTICS INC. 510(k) NO: K991617(TRADITIONAL)
ATTN: WALLY SIMPSON PHONE NO : 888 334 3565
6800 COLUMBUS ROAD SE DECISION MADE: 03-NOV-99
MISSISSAUGA, ONTARIO, CANADA L5T 2510(k) STATEMENT
DEVICE: ANTIBACTERIAL ADHESIVE BANDAGE
WILLIAM FEINSTEIN & ASSOCIATES, IN510(k) NO: K992817(TRADITIONAL)
ATTN: WILLIAM FEINSTEIN PHONE NO : 212-717-7131
330 EAST 75TH ST., SUITE 9F SE DECISION MADE: 05-NOV-99
NEW YORK, NY 10021 510(k) STATEMENT
DEVICE: WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
WORLDWIDE MEDICAL TECHNOLOGIES 510(k) NO: K991344(TRADITIONAL)
ATTN: GARY A LAMOUREUX PHONE NO : 203-263-2579
426 MAIN ST. NORTH SE DECISION MADE: 05-NOV-99
WOODBURY, CT 06798-0505 510(k) STATEMENT
DEVICE: Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
WR MEDICAL ELECTRONICS CO. 510(k) NO: K992874(TRADITIONAL)
ATTN: PATRICK J ANDERSON PHONE NO : 612-430-1200
123 NO.2ND.STREET SE DECISION MADE: 18-NOV-99
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K993311(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 19-NOV-99
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K993313(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 846 1486
LOT 1, JALAN 3, SE DECISION MADE: 23-NOV-99
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST
ZEUS SCIENTIFIC, INC. 510(k) NO: K993250(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 12-NOV-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 330
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 87
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