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510(k)s Final Decisions Rendered for September 2000 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-SEP-2000 THROUGH 30-SEP-2000 DEVICE: 3M RELY X VENEER CEMENT TRY-IN PASTER 3M CO. 510(k) NO: K002452(TRADITIONAL) ATTN: SHANNON PETTIT PHONE NO : 651-733-5027 3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 28-SEP-00 ST PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENX CODA AIR PURIFICATION SYSTEMINTL., INC. 510(k) NO: K001486(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 203-245-4901 170 FORT PATH ROAD SE DECISION MADE: 15-SEP-00 MADISON, CT 06443 510(k) STATEMENT DEVICE: MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MO ACRYMED, INC. 510(k) NO: K002599(TRADITIONAL) ATTN: BRUCE GIBBONS PHONE NO : 503-624-9830 12232 S.W. GARDEN PL. SE DECISION MADE: 21-SEP-00 PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIPORT ADVANCED SURGICAL CONCEPTS (ASC) 510(k) NO: K002013(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 29-SEP-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINK DIAGNOSTIC OFFLINE WORKSTATION ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K002144(TRADITIONAL) ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 28-SEP-00 P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041 DEVICE: HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A AGILENT TECHNOLOGIES, INC. 510(k) NO: K001725(TRADITIONAL) ATTN: RICHARD J PETERSEN PHONE NO : 978-659-2213 3000 MINUTEMAN RD. SE DECISION MADE: 08-SEP-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2 AGILENT TECHNOLOGIES, INC. 510(k) NO: K002470(TRADITIONAL) ATTN: ANN F MICHAELS PHONE NO : 978-659-2980 3000 MINUTEMAN RD. SE DECISION MADE: 08-SEP-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUIPMENT DRAPES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K002508(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 01-SEP-00 BUILDING WM 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROT ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K002701(TRADITIONAL) ATTN: CHUA HOOI KOON PHONE NO : 045 932 235 LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 13-SEP-00 PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT NINONG TEBAL, PULAU PINANG, MALAYSIA 14300 DEVICE: ALOKA UST-5280-5 ALOKA CO., LTD. 510(k) NO: K002784(TRADITIONAL) ATTN: CHRIS BOHL PHONE NO : 203-269-5088 10 FAIRFIELD BLVD. SE DECISION MADE: 20-SEP-00 WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORIMETRY, SALICYLATE APPLIED BIOTECH, INC. 510(k) NO: K001673(TRADITIONAL) ATTN: DAVE D SMITH PHONE NO : 858-713-9614 10237 FLANDERS CT. SE DECISION MADE: 15-SEP-00 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROW INTL., INC. 510(k) NO: K993933(TRADITIONAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 14-SEP-00 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C02 LASER MULTIPULSE ASCLEPION-MEDITEC AG 510(k) NO: K002032(TRADITIONAL) ATTN: DIRK COLDITZ PHONE NO : 493 641 653223 2525 MC GAW AVENUE SE DECISION MADE: 11-SEP-00 IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K001980(TRADITIONAL) ATTN: CHRISTINE M VOZELLA PHONE NO : 617-559-7028 141 NEEDHAM STREET SE DECISION MADE: 27-SEP-00 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K002734(SPECIAL) ATTN: CHRISTINE M VOZELLA PHONE NO : 617-559-7028 141 NEEDHAM STREET SE DECISION MADE: 14-SEP-00 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K002837(SPECIAL) ATTN: CHRISTINE M VOZELLA PHONE NO : 617-559-7028 141 NEEDHAM STREET SE DECISION MADE: 19-SEP-00 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GT ATRIX LABORATORIES, INC. 510(k) NO: K994137(TRADITIONAL) ATTN: AMY TAYLOR PHONE NO : 970-482-5868 2579 MIDPOINT DR. SE DECISION MADE: 13-SEP-00 FORT COLLINS, CO 80525-4417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAG AUGUSTINE MEDICAL, INC. 510(k) NO: K001149(TRADITIONAL) ATTN: SCOTT D AUGUSTINE PHONE NO : 952-947-1200 10393 WEST 70TH ST. SE DECISION MADE: 06-SEP-00 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS BAXTER HEALTHCARE CORP. 510(k) NO: K000664(TRADITIONAL) ATTN: PAULA A TORRIANNI PHONE NO : 949-250-2418 17221 RED HILL AVENUE (IRVINE) SE DECISION MADE: 20-SEP-00 P.O. BOX 11150 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA,, CA 92711-1150 DEVICE: INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP. 510(k) NO: K002380(TRADITIONAL) ATTN: VICKI L DREWS PHONE NO : 847-270-5916 RT. 120 AND WILSON ROAD SE DECISION MADE: 05-SEP-00 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL BAXTER HEALTHCARE CORP. 510(k) NO: K002679(SPECIAL) ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825 RT. 120 AND WILSON ROAD SE DECISION MADE: 18-SEP-00 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K BAXTER HEALTHCARE CORP. 510(k) NO: K002739(SPECIAL) ATTN: VICKI DREWS PHONE NO : 847-270-5619 RT. 120 & WILSON RD. SE DECISION MADE: 11-SEP-00 ROUND LAKE, IL 60073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYER IMMUNO 1 HER-2/NEU ASSAY BAYER CORP. 510(k) NO: K992228(TRADITIONAL) ATTN: GABRIEL J MURACA PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 29-SEP-00 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-LOGIC CEEGRAPH NETLINK BIO-LOGIC SYSTEMS CORP. 510(k) NO: K002570(SPECIAL) ATTN: NORMAN E BRUNNER PHONE NO : 847-949-5200 ONE BIO-LOGIC PLAZA SE DECISION MADE: 14-SEP-00 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 BIO-RAD LABORATORIES 510(k) NO: K002865(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 25-SEP-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 BIO-RAD LABORATORIES 510(k) NO: K002866(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 25-SEP-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BIOCHECK, INC. 510(k) NO: K001022(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 26-SEP-00 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: ASCENT KNEE SYSTEM BIOMET, INC. 510(k) NO: K002678(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-372-1612 56 EAST BELL DRIVE SE DECISION MADE: 19-SEP-00 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT XXL OPEN BOX FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K002735(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 P.O. BOX 587 SE DECISION MADE: 19-SEP-00 WARSAW, IN 46582-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET BIOMETRIX LTD. 510(k) NO: K001461(TRADITIONAL) ATTN: MIRIAM ABUTBUL PHONE NO : 972 258 61241 4 KIRYAT MADA, SE DECISION MADE: 11-SEP-00 P.O. BOX 45057 510(k) STATEMENT JERUSALEM, ISRAEL 91450 DEVICE: BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISEN BIONOSTICS INC. 510(k) NO: K002540(TRADITIONAL) ATTN: KATHLEEN STORRO PHONE NO : 978-263-3856 2 CRAIG RD. SE DECISION MADE: 18-SEP-00 ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSYS FETAL MONITOR, MODEL IFM-500 BIOSYS CO. LTD. 510(k) NO: K994008(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 29-SEP-00 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTELLATION CATHETERS BOSTON SCIENTIFIC CORP. 510(k) NO: K000277(SPECIAL) ATTN: ANDREA BOUMIS PHONE NO : 408-895-3625 2710 ORCHARD PKWY. SE DECISION MADE: 26-SEP-00 SAN JOSE, CA 95113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MOD BOSTON SCIENTIFIC/SCIMED 510(k) NO: K000743(TRADITIONAL) ATTN: DEBORAH A FRANK PHONE NO : 612-494-2831 ONE SCIMED PLACE SE DECISION MADE: 06-SEP-00 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN CARE 3000 BREG, INC. 510(k) NO: K002073(TRADITIONAL) ATTN: KATHLEEN BARBER PHONE NO : 760-599-5719 2611 COMMERCE WAY SE DECISION MADE: 19-SEP-00 VISTA, CA 92083 510(k) STATEMENT DEVICE: POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH C.R. BARD, INC. 510(k) NO: K001901(TRADITIONAL) ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 19-SEP-00 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE CALIFORNIA MEDICAL LABORATORIES, I510(k) NO: K000830(TRADITIONAL) ATTN: MEHMET BICAKCI PHONE NO : 949-553-9414 2681 KELVIN AVENUE SE DECISION MADE: 07-SEP-00 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA SPTL-1B PULSED DYE LASER CANDELA CORP. 510(k) NO: K001093(TRADITIONAL) ATTN: JOAN M CLIFFORD PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 19-SEP-00 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 CAS MEDICAL SYSTEMS, INC. 510(k) NO: K000512(TRADITIONAL) ATTN: RON JEFFREY PHONE NO : 203-488-6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 26-SEP-00 BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D CITIZEN WATCH CO., LTD. 510(k) NO: K001244(TRADITIONAL) ATTN: JOSEPH D EDMONDSON PHONE NO : 202-672-5354 3000 K STREET N.W. SE DECISION MADE: 26-SEP-00 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20007 DEVICE: COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. 510(k) NO: K002591(SPECIAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 13-SEP-00 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 CODAN US CORP. 510(k) NO: K001872(TRADITIONAL) ATTN: RICHARD A BASLER PHONE NO : 949-551-6989 15412 VERDUN CIRCLE SE DECISION MADE: 07-SEP-00 IRVINE, CA 92604 510(k) STATEMENT DEVICE: AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K002215(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 441 314 457111 BUSH LOAN SE DECISION MADE: 28-SEP-00 PENICUIK 510(k) STATEMENT MIDLOTHIAN EH26 0PL, UNITED KINGDOM EH26 OPL DEVICE: COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM COOK OB/GYN 510(k) NO: K002383(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 13-SEP-00 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK OB/GYN 510(k) NO: K002385(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-6500 1100 W. MORGAN STREET SE DECISION MADE: 18-SEP-00 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEZER TEETHER COOL BABY, INC. 510(k) NO: K002066(TRADITIONAL) ATTN: DEWAYNE MOORE PHONE NO : 405-359-1998 17620 CRANBROOK ROAD SE DECISION MADE: 26-SEP-00 EDMOND, OK 73003 510(k) STATEMENT DEVICE: METHAFILCON A COOPERVISION, INC. 510(k) NO: K002625(TRADITIONAL) ATTN: BONNIE TSYMBAL PHONE NO : 716-264-3210 711 NORTH RD. SE DECISION MADE: 13-SEP-00 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRIDIS LASER COSMOS MEDICAL TECHNOLOGY 510(k) NO: K001784(TRADITIONAL) ATTN: JOHN CLARK PHONE NO : 909-587-6306 42230 ZEVO DR. SE DECISION MADE: 11-SEP-00 TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DINAMAP PRO 1000 MONITOR, MODEL 1000 CRITIKON COMPANY,LLC 510(k) NO: K002248(TRADITIONAL) ATTN: THOMAS J ENGLISH PHONE NO : 813-887-2107 4502 WOODLAND CORPORATE BLVD. SE DECISION MADE: 21-SEP-00 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT CTI PET SYSTEMS, INC. 510(k) NO: K002039(TRADITIONAL) ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522 810 INNOVATION DR. SE DECISION MADE: 27-SEP-00 KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BN PROSPEC SYSTEM DADE BEHRING, INC. 510(k) NO: K001647(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 26-SEP-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: PROTEIN C REAGENT DADE BEHRING, INC. 510(k) NO: K002541(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 P.O. BOX 6101 SE DECISION MADE: 26-SEP-00 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWA DATEX-OHMEDA, INC. 510(k) NO: K002158(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 978-640-0460 3 HIGHWOOD DR. SE DECISION MADE: 06-SEP-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER DATEX-OHMEDA, INC. 510(k) NO: K002878(SPECIAL) ATTN: DANIEL KOSEDNAR PHONE NO : 608-221-1551 OHMEDA DR. SE DECISION MADE: 21-SEP-00 P.O. BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA MADISON, WI 53707-7550 DEVICE: SUPER 3 DENTAL ALLOY PRODUCTS, INC. 510(k) NO: K002299(TRADITIONAL) ATTN: RODNEY GUYTON PHONE NO : 310-637-9711 1190 MAHALO PLACE SE DECISION MADE: 08-SEP-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: SUPER 6 DENTAL ALLOY PRODUCTS, INC. 510(k) NO: K002300(TRADITIONAL) ATTN: RODNEY GUYTON PHONE NO : 310-637-8711 1190 MAHALO PLACE SE DECISION MADE: 26-SEP-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: SUPER 12 DENTAL ALLOY PRODUCTS, INC. 510(k) NO: K002301(TRADITIONAL) ATTN: RODNEY GUYTON PHONE NO : 310-637-9711 1190 MAHALO PLACE SE DECISION MADE: 08-SEP-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: SUPER 14 DENTAL ALLOY PRODUCTS, INC. 510(k) NO: K002302(TRADITIONAL) ATTN: RODNEY GUYTON PHONE NO : 310-637-9711 1190 MAHALO PLACE SE DECISION MADE: 26-SEP-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: COMFORT CONTROL SYRINGE SYSTEM DENTSPLY INTL. 510(k) NO: K002387(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 28-SEP-00 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTI DEPUY ACROMED 510(k) NO: K002607(SPECIAL) ATTN: LISA GILMAN PHONE NO : 508-880-8287 325 PARAMOUNT DR. SE DECISION MADE: 12-SEP-00 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FENNING HIP STEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K002441(TRADITIONAL) ATTN: ARLENE C SAULL PHONE NO : 219-371-4904 700 ORTHOPAEDIC DR. SE DECISION MADE: 01-SEP-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELVX GELLHORN VAGINAL PESSARY 603-608 DESCHUTES MEDICAL PRODUCTS, INC. 510(k) NO: K002329(TRADITIONAL) ATTN: DENISE BESTWICK PHONE NO : 541-385-0350 1011 S.W. EMKAY DR., SUITE 104 SE DECISION MADE: 18-SEP-00 BEND, OR 97702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K002354(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 26-SEP-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K002694(SPECIAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 15-SEP-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: LINEZOLID, 30UG, BBL SENSI-DISC DICKINSON, AND COMPANY 510(k) NO: K002165(TRADITIONAL) ATTN: BRADFORD SPRING PHONE NO : 410-316-4206 7 LOVETON CIRCLE SE DECISION MADE: 05-SEP-00 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE BRANDS DONGKUK TECHCO RUBBER INDUSTRIES 510(k) NO: K002060(ABBREVIATED) ATTN: PETER PARK PHONE NO : 604 261 0600 3 PENANG STREET SE DECISION MADE: 07-SEP-00 7TH FL., MAYBAN TRUST BLDG. 510(k) STATEMENT PENANG, MALAYSIA 10200 DEVICE: KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY EASTMAN KODAK CO. 510(k) NO: K002146(TRADITIONAL) ATTN: STEPHEN G SLAVENS PHONE NO : 651-393-1395 1 IMATION PL. SE DECISION MADE: 27-SEP-00 304-4B-75 510(k) SUMMARY AVAILABLE FROM FDA OAKDALE, MN 55128-3414 DEVICE: ATAC PAK ALP REAGENT KIT ELAN DIAGNOSTICS 510(k) NO: K002285(TRADITIONAL) ATTN: WYNN STOCKING PHONE NO : 714-871-8360 231 NORTH PUENTE ST. SE DECISION MADE: 26-SEP-00 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGITRON IEC II ELLMAN INTL., INC. 510(k) NO: K001986(TRADITIONAL) ATTN: FRANK LIN PHONE NO : 516-569-1482 1135 RAILROAD AVE., SE DECISION MADE: 27-SEP-00 ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA HEWLETT, NY 11557 DEVICE: BRAVO PH MONITORING SYSTEM ENDONETICS, INC. 510(k) NO: K002028(TRADITIONAL) ATTN: WILLIAM A KNAPE PHONE NO : 408-399-9347 987 UNIVERSITY AVE.;STE. 14 SE DECISION MADE: 29-SEP-00 LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KETAC CEM U ESPE DENTAL AG 510(k) NO: K002793(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 26-SEP-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502J FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K002414(TRADITIONAL) ATTN: BRETT WHISTON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PL., SE DECISION MADE: 25-SEP-00 EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FMS SOLO FUTURE MEDICAL SYSTEMS, INC. 510(k) NO: K002040(TRADITIONAL) ATTN: PATRICK JANIN PHONE NO : 410-761-9411 504 MCCORMICK DR. SE DECISION MADE: 11-SEP-00 GLEN GURNIE, MD 21061 510(k) STATEMENT DEVICE: THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES HAEMOSCOPE CORP. 510(k) NO: K002177(TRADITIONAL) ATTN: ELI COHEN PHONE NO : 847-329-0001 7855 GROSS POINT RD., UNIT G-4 SE DECISION MADE: 14-SEP-00 SKOKIE, IL 60077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ HAI LABORATORIES, INC. 510(k) NO: K994340(ABBREVIATED) ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059 30 NORTHPOINT ROAD SE DECISION MADE: 20-SEP-00 SOUND BEACH, NY 11789-1734 510(k) STATEMENT DEVICE: IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08 HDC CORP. 510(k) NO: K002770(SPECIAL) ATTN: EARL SMART PHONE NO : 408-954-1909 2109 O'TOOLE AVE. SE DECISION MADE: 26-SEP-00 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: HL168T HEALTH & LIFE CO., LTD. 510(k) NO: K002750(SPECIAL) ATTN: PAUL YANG PHONE NO : 886 232 349600 6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 18-SEP-00 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) 235 DEVICE: ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST HELIX DIAGNOSTICS, INC. 510(k) NO: K001900(TRADITIONAL) ATTN: VIRGINIA CAPPEL PHONE NO : 916-372-6221 3148 INDUSTRIAL BLVD. SE DECISION MADE: 11-SEP-00 WEST SACRAMENTO, CA 95691 510(k) STATEMENT DEVICE: HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 20 HOLOGIC, INC. 510(k) NO: K002711(TRADITIONAL) ATTN: DENISE DUCHENE PHONE NO : 781-999-7300 35 CROSBY DR. SE DECISION MADE: 28-SEP-00 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCOLADE C FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP. 510(k) NO: K002320(TRADITIONAL) ATTN: NANCY J RIEDER PHONE NO : 201-507-7956 359 VETERANS BLVD. SE DECISION MADE: 14-SEP-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOWMEDICA OSTEONICS SHOULDER SCREW HOWMEDICA OSTEONICS CORP. 510(k) NO: K002654(SPECIAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283 359 VETERANS BLVD. SE DECISION MADE: 22-SEP-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABY DOPPLEX 4002-TWINS, MODEL BD4002 HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K001882(TRADITIONAL) ATTN: AUDREY A WITKO PHONE NO : 800-223-1218 40 CHRISTOPHER WAY SE DECISION MADE: 19-SEP-00 EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPI HUMIDIFIER CHAMBER I.P.I. MEDICAL PRODUCTS 510(k) NO: K993282(TRADITIONAL) ATTN: MAZH SAID, PH.D PHONE NO : 773-777-0900 3217 N. KILPATRICK AVENUE SE DECISION MADE: 18-SEP-00 CHICAGO, IL 60641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000138(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000139(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000141(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000142(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000143(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE INDUSTRIAL CLOTHINGS LIMITED 510(k) NO: K000145(TRADITIONAL) ATTN: SYED UMAIR AHMED PHONE NO : 941 437 575 481 A, PRINCE OF WALES AVE. SE DECISION MADE: 13-SEP-00 COLUMBO 14, SRI LANKA 14 510(k) STATEMENT DEVICE: PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, INTERPORE CROSS INTL. 510(k) NO: K000515(TRADITIONAL) ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 15-SEP-00 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILT 0.014" CATHETER, MODEL C114NL2 INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K001992(TRADITIONAL) ATTN: PAMELA MISAJON PHONE NO : 760-918-1820 6354 CORTE DEL ABETO SE DECISION MADE: 25-SEP-00 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92009 DEVICE: OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL INVIVO RESEARCH, INC. 510(k) NO: K002030(TRADITIONAL) ATTN: FRANCIS CASEY PHONE NO : 407-275-3220 12601 RESEARCH PKWY. SE DECISION MADE: 26-SEP-00 ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 JAWON MEDICAL CO., LTD. 510(k) NO: K002722(SPECIAL) ATTN: WON-HEE PARK PHONE NO : 82 258 74056 7F JEONG JU BLDG. SE DECISION MADE: 11-SEP-00 SEOCHO-DONG. SEOCHO-KU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 1451-38 DEVICE: FREEDOM, MODEL 4660 JOHNSON & JOHNSON CONSUMER COMPANI510(k) NO: K001023(TRADITIONAL) ATTN: JOSEPH KICEINA PHONE NO : 908-874-1216 199 GRANDVIEW ROAD SE DECISION MADE: 22-SEP-00 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA PERCUTANEOUS FORAMINOSCOPY SET KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K001918(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 19-SEP-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYS KEYSTONE MEDICAL 510(k) NO: K001958(TRADITIONAL) ATTN: ALAN P SCHWARTZ PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 25-SEP-00 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PANAVIA F KURARAY AMERICA, INC. 510(k) NO: K002322(TRADITIONAL) ATTN: KOICHI KIKUCHI PHONE NO : 212-986-2230 200 PARK AVE. SE DECISION MADE: 18-SEP-00 NEW YORK, NY 10166-3098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASORB SUTURE ANCHOR LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K002413(TRADITIONAL) ATTN: RHODEMANN LI PHONE NO : 203-944-2800 4 ARMSTRONG RD. SE DECISION MADE: 19-SEP-00 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMID-HEAT LOUIS GIBECK AB 510(k) NO: K993773(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 612-574-1976 6470 RIVERVIEW TERRACE SE DECISION MADE: 13-SEP-00 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZORTRAN DETECTOR LUCENT MEDICAL SYSTEMS 510(k) NO: K000997(TRADITIONAL) ATTN: CINDY PESTKA PHONE NO : 425-822-3310 135 LAKE STREET SOUTH SE DECISION MADE: 07-SEP-00 # 250 510(k) SUMMARY AVAILABLE FROM FDA KIRKLAND, WA 98033 DEVICE: MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT MAGNA FORTIS CORP. 510(k) NO: K002044(TRADITIONAL) ATTN: MARK WERBLUD PHONE NO : 425-747-9851 13606 NE 20TH STREET SE DECISION MADE: 12-SEP-00 BELLEVUE, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOLUSPRO ULTRA MARCONI MEDICAL SYSTEMS INC. 510(k) NO: K002005(TRADITIONAL) ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528 5595 MINER ROAD SE DECISION MADE: 22-SEP-00 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTAC MARIETTA CONTACT LENS SERVICE 510(k) NO: K002647(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 13-SEP-00 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES MASIMO CORP. 510(k) NO: K002477(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 08-SEP-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES MASIMO CORP. 510(k) NO: K002574(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 06-SEP-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K002682(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 13-SEP-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER MEDI-DYNE, INC. 510(k) NO: K000825(TRADITIONAL) ATTN: NORMAN HALL PHONE NO : 518-792-2183 604 QUEENSBURY AVE. SE DECISION MADE: 21-SEP-00 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: PROLITE VL PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB 510(k) NO: K002072(TRADITIONAL) ATTN: CONNIE WHITE HOY PHONE NO : 505-323-2403 9630 TOWNER NE SE DECISION MADE: 11-SEP-00 ALBUQUERQUE, NM 87112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLDEN-RULE SCALING CATHETER MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K002416(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 352-338-0440 3600 S.W. 47TH AVE. SE DECISION MADE: 11-SEP-00 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: PRONTO DRY MEDICAL INSTRUMENTS CORPORATION, A510(k) NO: K002451(TRADITIONAL) ATTN: JOHN C MATHERLY PHONE NO : 413 262 34355 POB 706 CH-4502 SE DECISION MADE: 29-SEP-00 SOLOTHURN, SWITZERLAND CH-4502 510(k) STATEMENT DEVICE: DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODER MEDICOTEST A/S 510(k) NO: K001869(TRADITIONAL) ATTN: EMALEE G MURPHY PHONE NO : 202-496-7500 1900 K STREET N.W. SE DECISION MADE: 18-SEP-00 WASHINGTON, DC 20006-1108 510(k) STATEMENT DEVICE: CORDLESS COMPACT MOBILE X-RAY SYSTEM MEDISON RADIOLOGY SYSTEMS, INC. 510(k) NO: K002685(ABBREVIATED) ATTN: JOHN W LEE PHONE NO : 847-291-0999 151 SOUTH PFINGSTEN ROAD SE DECISION MADE: 15-SEP-00 DEERFIELD,, IL 60015 510(k) STATEMENT DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 MEDITEC CO., LTD. 510(k) NO: K002655(TRADITIONAL) ATTN: D H CHANG PHONE NO : 011 823 17072701 SE DECISION MADE: 06-SEP-00 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE ELECTRONIC POSITIONING CHAIR MEDLINE INDUSTRIES, INC. 510(k) NO: K001937(TRADITIONAL) ATTN: LARA SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 22-SEP-00 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MODIFICATION TO PROFILE -II MEDTOX DIAGNOSTICS, INC. 510(k) NO: K002776(SPECIAL) ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311 1238 ANTHONY RD. SE DECISION MADE: 28-SEP-00 BURLINGTON, NC 27215 510(k) STATEMENT DEVICE: WIRE, GUIDE, CATHETER, MODEL QSW1000 MEDTRONIC AVE, INC. 510(k) NO: K002346(SPECIAL) ATTN: LINDA (LINN) LAAK PHONE NO : 763-577-9988 1660 WAYZATA BOULEVARD SE DECISION MADE: 27-SEP-00 MINNETONKA, MN 55305 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20 MEDTRONIC PS MEDICAL 510(k) NO: K991502(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR., SE DECISION MADE: 12-SEP-00 UNIVERSITY BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K002399(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 27-SEP-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX HBA1C - FOR PRESCRIPTION HOME USE METRIKA, INC. 510(k) NO: K000885(TRADITIONAL) ATTN: JOEL M BLATT PHONE NO : 408-524-2255 510 OAKMEAD PARKWAY SE DECISION MADE: 26-SEP-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICOR CONDUCTION CATHETER MICOR INC. 510(k) NO: K001717(TRADITIONAL) ATTN: JEREMIAH COSTELLO PHONE NO : 412-487-1113 2855 OXFORD BLVD. SE DECISION MADE: 20-SEP-00 ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS MICRO THERAPEUTICS, INC. 510(k) NO: K002723(SPECIAL) ATTN: MARIBELLE AGUINALDO PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 28-SEP-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFRACTIVE SURGERY BLADES MILLENNIUM BIOMEDICAL, INC. 510(k) NO: K001806(TRADITIONAL) ATTN: JERRY KAENI PHONE NO : 909-621-7646 360 EAST BONITA AVE. SE DECISION MADE: 12-SEP-00 POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBC-63 MEBREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K002602(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 05-SEP-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: MOTOR-DRIVE MANIPULATOR MM-89 NARISHIGE CO., LTD. 510(k) NO: K002291(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 13-SEP-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE NARISHIGE CO., LTD. 510(k) NO: K002293(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 13-SEP-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MMN-1 COARSE MANIPULATOR NARISHIGE CO., LTD. 510(k) NO: K002653(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-SEP-00 SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR NARISHIGE CO., LTD. 510(k) NO: K002658(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-SEP-00 SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULA NARISHIGE CO., LTD. 510(k) NO: K002659(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-SEP-00 SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICORE MODEL ESP -1 NICORE EQUIPMENT & LEASING, INC. 510(k) NO: K980937(TRADITIONAL) ATTN: JOHN F SPANGLER PHONE NO : 813-259-0348 1625 K STREET, NW, SUITE 1000 SE DECISION MADE: 15-SEP-00 WASHINGTON, DC 20006-1604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INPLANT ORTHODONTIC ANCHOR SYSTEM NOBEL BIOCARE USA, INC. 510(k) NO: K000643(TRADITIONAL) ATTN: JEFF HAUSHEER PHONE NO : 714-282-4800 22725 SAVI RANCH PKWY. SE DECISION MADE: 07-SEP-00 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPIDURE REWETTING DROPS NOF CORPORATION 510(k) NO: K000975(TRADITIONAL) ATTN: ANN KUROWSKI PHONE NO : 978-658-6888 269A BALLARDVALE STREET SE DECISION MADE: 25-SEP-00 WILMINGTON, MA 01887 510(k) STATEMENT DEVICE: PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM NOMOS CORP. 510(k) NO: K993675(TRADITIONAL) ATTN: FRANCIS X DOBSCHA PHONE NO : 724-934-8242 2591 WEXFORD BAYNE RD., #400 SE DECISION MADE: 05-SEP-00 SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREFERENCE TREATMENT SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMEN510(k) NO: K001833(SPECIAL) ATTN: LEE MYERS PHONE NO : 425-672-2841 21031 67TH AVE. WEST SE DECISION MADE: 28-SEP-00 LYNNWOOD, WA 98036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYSHAK, MODEL 102 AND Z-MED, MODEL 302 NUMED, INC. 510(k) NO: K991977(TRADITIONAL) ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491 2880 MAIN STREET SE DECISION MADE: 27-SEP-00 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE MICROKERATOME BLADES-PE OASIS MEDICAL, INC. 510(k) NO: K001176(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 626-914-2891 514 S. VERMONT AVE. SE DECISION MADE: 21-SEP-00 GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLESTAR N-10 ODIN TECHNOLOGIES LTD. 510(k) NO: K002242(TRADITIONAL) ATTN: ADI ICKOWICZ PHONE NO : 972 4 9591010 P.O. BOX 248 SE DECISION MADE: 20-SEP-00 YOKNEAM ELIT, ISRAEL 20698 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPIC WARM-UP OLYMPIC MEDICAL CORP. 510(k) NO: K001056(TRADITIONAL) ATTN: JOSEPH P STEFANILE PHONE NO : 206-767-3500 5900 FIRST AVE., SOUTH SE DECISION MADE: 29-SEP-00 SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQU OLYMPUS AMERICA, INC. 510(k) NO: K994103(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 05-SEP-00 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE OLYMPUS OPTICAL CO., LTD. 510(k) NO: K001766(TRADITIONAL) ATTN: LAURA STORMS-TAYLOR PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 08-SEP-00 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) ONCOGENE SCIENCE, INC. 510(k) NO: K994112(TRADITIONAL) ATTN: WALTER P CARNEY PHONE NO : 617-492-7289 80 ROGERS ST. SE DECISION MADE: 29-SEP-00 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR OON CORP. RESOURCES 510(k) NO: K002448(TRADITIONAL) ATTN: CLEMENT K K OON PHONE NO : 066 780 833 59 SENAWANG INDUSTRIAL ESTATE SE DECISION MADE: 11-SEP-00 SEREMBAN, MALAYSIA 70450 510(k) STATEMENT DEVICE: ORALUBE ORASYSTEMS, LLC 510(k) NO: K000847(TRADITIONAL) ATTN: BERNARD SESSMAN PHONE NO : 973-267-5632 764 SPEEDWELL AVE. SE DECISION MADE: 27-SEP-00 SUITE 4 510(k) STATEMENT MORRIS PLAINS, NJ 07950-2231 DEVICE: RAEBBITT/EVOLUTION POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000678(TRADITIONAL) ATTN: WILLIAM JACKSON PHONE NO : 651-773-0002 3000 XENIUM LANE, SUITE N SE DECISION MADE: 18-SEP-00 PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM OXFORD INSTRUMENTS 510(k) NO: K002544(SPECIAL) ATTN: BARRY BRIGHT PHONE NO : 148 377 0331 MANOR WAY SE DECISION MADE: 13-SEP-00 OLD WOKING, SURREY, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOUD CUFF PARTS PORT, LTD. 510(k) NO: K002360(TRADITIONAL) ATTN: CATHY SEBASTIAN PHONE NO : 804-530-1233 1801 WALTHALL CREEK DR. SE DECISION MADE: 26-SEP-00 COLONIAL HEIGHTS, VA 23834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUAR PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K002111(TRADITIONAL) ATTN: PETER YEW NIENG CHOON PHONE NO : 606 677 2781 EMPAT, SENAWANG INDUSTRIAL SE DECISION MADE: 08-SEP-00 ESTATE, 70450 SEREMBAN, NEGERI 510(k) SUMMARY AVAILABLE FROM FDA SEMBILAN DARUL KHUSUS MALAYSIA, MALI DEVICE: GYROSCAN INTERA (R7.5) PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K001796(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVE. SE DECISION MADE: 06-SEP-00 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLORER GRADIENT PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K001987(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVENUE SE DECISION MADE: 06-SEP-00 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-0917 DEVICE: PHILIPS INTEGRIS ALLURA PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K002016(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVE. SE DECISION MADE: 06-SEP-00 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS PILLING WECK SURGICAL 510(k) NO: K992476(TRADITIONAL) ATTN: RICHARD G JONES PHONE NO : 800-523-6507 420 DELAWARE DR. SE DECISION MADE: 13-SEP-00 FORT WASHINGTON, PA 19034 510(k) STATEMENT DEVICE: SERAGARD VASCULAR ACCESS PATCH PLATINUM SERVICES, INC. 510(k) NO: K001175(TRADITIONAL) ATTN: NANCY Y STREET PHONE NO : 337-786-2911 115 BOISE STREET SE DECISION MADE: 18-SEP-00 DEQUINCY, LA 70633 510(k) STATEMENT DEVICE: P.O.P. PAIN KIT POST OPERATIVE PAIN MANAGEMENT 510(k) NO: K001342(TRADITIONAL) ATTN: CHARLES ROWLAND II PHONE NO : 440-526-5104 1 CORPORATE CENTER SE DECISION MADE: 07-SEP-00 BROADVIEW HEIGHTS, OH 44147 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET 1 POWERED WHEELCHAIR PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K001970(TRADITIONAL) ATTN: GENE KULON PHONE NO : 570-655-5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 26-SEP-00 EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K001951(TRADITIONAL) ATTN: KATHERINE CO PHONE NO : 780 497 7600 10707 100TH AVE., SUITE 300 SE DECISION MADE: 08-SEP-00 EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) STATEMENT DEVICE: TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TA PROCTER & GAMBLE CO. 510(k) NO: K002096(TRADITIONAL) ATTN: MARK M ANDERSON PHONE NO : 513-643-5196 6100 CENTER HILL AVENUE SE DECISION MADE: 08-SEP-00 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSTEC 125I BRANCHYTHERAPY SNAPSEED PROSTEC LLC 510(k) NO: K001366(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 19526 EAST LAKE DRIVE SE DECISION MADE: 19-SEP-00 MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREEZE SLEEPGEAR WITH DREAMSEAL PURITAN BENNETT CORP. 510(k) NO: K002001(SPECIAL) ATTN: DARIN BUSCH PHONE NO : 763-694-3563 2800 NORTHWEST BLVD. SE DECISION MADE: 06-SEP-00 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION PATIENT GLOVES PURNABINA SDN BHD 510(k) NO: K994420(TRADITIONAL) ATTN: LIEW YOON FONG PHONE NO : 607 787 9128 PLOT 5, JALAN MAHSURI 1, 7.5KM SE DECISION MADE: 18-SEP-00 J. MERSING, KLUANG IND. AREA 510(k) STATEMENT KLUANG, JOHOR D. TAKZIM, MALAYSIA 86000 DEVICE: BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MI QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K002087(TRADITIONAL) ATTN: ZECHUAN SHAO PHONE NO : 408-739-4729 205 NORTH BAYVIEW AVE. SE DECISION MADE: 13-SEP-00 UNIT 4 510(k) STATEMENT SUNNYVALE, CA 94086 DEVICE: SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER QRS DIAGNOSTIC, LLC 510(k) NO: K001995(SPECIAL) ATTN: JILL R KRALL PHONE NO : 763-559-8560 14755 27TH AVE.NORTH SE DECISION MADE: 08-SEP-00 PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST MPS BACK-UP SYSYEM QUEST MEDICAL, INC. 510(k) NO: K002366(TRADITIONAL) ATTN: DOUG BRYAN PHONE NO : 972-390-9800 ONE ALLENTOWN PKWY. SE DECISION MADE: 18-SEP-00 ALLEN, TX 75002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTI-FLEX IV ADMINISTRATION SET R-GROUP INTL. 510(k) NO: K001599(TRADITIONAL) ATTN: KERRY ANNE KAHN PHONE NO : 352-378-3633 2321 N.W. 66TH CT., SUITE W-4 SE DECISION MADE: 18-SEP-00 GAINESVILLE, FL 32653 510(k) STATEMENT DEVICE: ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) RADIOMETER MEDICAL A/S 510(k) NO: K002290(TRADITIONAL) ATTN: KIRSTEN RONO PHONE NO : 45 382 73827 AKANDEVEJ 21 SE DECISION MADE: 13-SEP-00 BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 RESPIRONICS, INC. 510(k) NO: K000705(ABBREVIATED) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 08-SEP-00 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 RESPIRONICS, INC. 510(k) NO: K002465(SPECIAL) ATTN: DAVID J VANELLA PHONE NO : 724-733-5866 1001 MURRY RIDGE LANE SE DECISION MADE: 08-SEP-00 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUWARM EMG HEAT LAMP RJL ASSOCIATES, LLC 510(k) NO: K001800(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-437-4609 86-3 BOSTON POST RD. SE DECISION MADE: 12-SEP-00 WATERFORD, CT 06385 510(k) STATEMENT DEVICE: CAMIT DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP. 510(k) NO: K001907(TRADITIONAL) ATTN: MIKE FLIS PHONE NO : 317-576-3830 9115 HAGUE RD. SE DECISION MADE: 05-SEP-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K002609(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 05-SEP-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK S SYSTEM, MODEL 2138280 ROCHE DIAGNOSTICS CORP. 510(k) NO: K994349(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742 9115 HAGUE ROAD SE DECISION MADE: 06-SEP-00 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: INVIDOS SCANDITRONIX MEDICAL AB 510(k) NO: K002051(TRADITIONAL) ATTN: EVA LARSTEN PHONE NO : 461 818 0700 STALGATAN 14 SE DECISION MADE: 05-SEP-00 UPPSALA S-754 50, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE SEMLER TECHNOLOGIES, INC. 510(k) NO: K002767(SPECIAL) ATTN: HERBERT J SEMLER PHONE NO : 360-699-3000 501 S.E. COLUMBIA SHORES BLVD. SE DECISION MADE: 27-SEP-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA VANCOUVER, WA 98661-8064 DEVICE: HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT SHOFU DENTAL CORP. 510(k) NO: K002461(TRADITIONAL) ATTN: CINDY RHOADES PHONE NO : 650-324-0085 4024 BOHANNON DR. SE DECISION MADE: 26-SEP-00 MENLO PARK, CA 94025-1096 510(k) STATEMENT DEVICE: DS DS I-SERIES SMV AMERICA 510(k) NO: K002553(SPECIAL) ATTN: LONNIE MIXON PHONE NO : 330-425-1340 8380 DARROW RD. SE DECISION MADE: 15-SEP-00 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 SOMANETICS CORP. 510(k) NO: K001842(TRADITIONAL) ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050 1653 EAST MAPLE RD. SE DECISION MADE: 15-SEP-00 TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOPHY SU8 PRESSURE ADJUSTABLE VALVE SOPHYSA SA 510(k) NO: K992465(TRADITIONAL) ATTN: JACQUELINE MASSE PHONE NO : 781-239-8108 70 WALNUT STREET SE DECISION MADE: 21-SEP-00 WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM SPINEOLOGY GROUP, LLC 510(k) NO: K002371(ABBREVIATED) ATTN: PAMELA SNYDER PHONE NO : 651-351-1011 1815 NORTHWESTERN AVE. SE DECISION MADE: 15-SEP-00 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER STANDARD IMAGING, INC. 510(k) NO: K002833(SPECIAL) ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025 7601 MURPHY DRIVE SE DECISION MADE: 28-SEP-00 MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT STELKAST CO. 510(k) NO: K001984(TRADITIONAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. #210 SE DECISION MADE: 27-SEP-00 PITTSBURGH, PA 15212 510(k) STATEMENT DEVICE: MODIFICATION TO PROVIDENT HIP SYSTEM STELKAST CO. 510(k) NO: K002796(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. #210 SE DECISION MADE: 28-SEP-00 PITTSBURGH, PA 15212 510(k) STATEMENT DEVICE: INSIGHT IMAGE GUIDED SURGICAL SYSTEM SURGICAL INSIGHTS, INC. 510(k) NO: K001642(TRADITIONAL) ATTN: JON T LEA PHONE NO : 847-866-1816 1840 OAK AVENUE SE DECISION MADE: 12-SEP-00 EVANSTON, IL 60201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOOK COLLAGEN SPACERS, MODEL 1514B SURGICAL SPECIALTIES CORP. 510(k) NO: K001765(TRADITIONAL) ATTN: LINDA F TEXTER PHONE NO : 610-404-1000 100 DENNIS DR. SE DECISION MADE: 07-SEP-00 READING, PA 19606 510(k) STATEMENT DEVICE: SYNTHES MODULAR FOOT SYSTEM SYNTHES (USA) 510(k) NO: K001941(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 22-SEP-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES SYNTHES (USA) 510(k) NO: K001945(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 22-SEP-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: USS VAS SYNTHES (USA) 510(k) NO: K002517(TRADITIONAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 12-SEP-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TS SYNTHES (USA) 510(k) NO: K002710(SPECIAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 29-SEP-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX ARTERIAL FILTER TERUMO MEDICAL CORPORATION 510(k) NO: K002026(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 06-SEP-00 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS SONOSURG TROCAR XT3900 SYSTEM THE OLYMPUS OPTICAL CO. 510(k) NO: K000095(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : TWO CORPORATE DRIVE SE DECISION MADE: 26-SEP-00 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EL-ANA PROFILES-2K1 THERATEST LABORATORIES, INC. 510(k) NO: K002559(TRADITIONAL) ATTN: MARIUS TEODORESCU PHONE NO : 312-226-2283 2201 WEST CAMPBELL PARK DR. SE DECISION MADE: 12-SEP-00 CHICAGO, IL 60612-3501 510(k) STATEMENT DEVICE: VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, S THORATEC LABORATORIES CORP. 510(k) NO: K001926(TRADITIONAL) ATTN: DONALD A MIDDLEBROOK PHONE NO : 925-847-8600 6035 STONERIDGE DR. SE DECISION MADE: 22-SEP-00 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETALTROL TRILLIUM DIAGNOSTICS, LLC. 510(k) NO: K002511(TRADITIONAL) ATTN: BRUCE H DAVIS PHONE NO : 207-842-7914 5 TAMARLANE SE DECISION MADE: 11-SEP-00 PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCCU-FLO PUNCTUM PLUGS U.S. IOL, INC. 510(k) NO: K001768(TRADITIONAL) ATTN: TERESA BURTON PHONE NO : 859-259-4925 2500 SANDERSVILLE RD. SE DECISION MADE: 19-SEP-00 LEXINGTON, KY 40511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIPHERALLY INSERTED CENTRAL CATHETER UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K001874(TRADITIONAL) ATTN: KEVIN L CORNWELL PHONE NO : 801-569-4039 7043 SOUTH 300 WEST SE DECISION MADE: 25-SEP-00 MIDVALE, UT 84047-1048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATO X VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K002432(TRADITIONAL) ATTN: JEFF MOELLER PHONE NO : 847-288-7000 11550 WEST KING STREET SE DECISION MADE: 01-SEP-00 CHICAGO, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH BASE STATION VITALOGRAPH INC. 510(k) NO: K000599(TRADITIONAL) ATTN: PHIL HEMES PHONE NO : 913-888-4221 8347 QUIVIRA RD. SE DECISION MADE: 08-SEP-00 LENEXA, KS 66215 510(k) STATEMENT DEVICE: LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) WOLFE TORY MEDICAL, INC. 510(k) NO: K002255(TRADITIONAL) ATTN: TIM WOLFE PHONE NO : 801-281-3000 79 WEST 4500 SOUTH, SUITE 21 SE DECISION MADE: 18-SEP-00 SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K002579(TRADITIONAL) ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 60 3 87069788 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 08-SEP-00 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: BUFFLIGHT CLT SURGICAL LASER SYSTEM Y-BEAM TECHNOLOGIES, INC. 510(k) NO: K000727(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 19-SEP-00 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION ZOLL MEDICAL CORP. 510(k) NO: K002029(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 781-229-0020 32 SECOND AVE. SE DECISION MADE: 21-SEP-00 BURLINGTON, MA 01803 510(k) STATEMENT DEVICE: ZYBIT ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K002004(TRADITIONAL) ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941 1201 B NORTH RICE AVENUE SE DECISION MADE: 21-SEP-00 OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 199 TOTAL WITH SUMMARIES 148 TOTAL WITH STATEMENTS 51
Updated 5/2/2001
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