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Medical Devices
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September 2000 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-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 SYSTEM
GENX INTL., 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
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