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510(k)s Final Decisions Rendered for Auguat 1999 |
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DEVICE: HOFFMAN IVF-1
(ARMS) HOFFMAN SURGICAL EQUIPMENT,510(k) NO: K991216(TRADITIONAL)
ATTN: FRANK STRZEMPEK PHONE NO : 610-834-1450
555 NORTH LANE SE DECISION MADE: 05-AUG-99
SUITE 5001 510(k) STATEMENT
CONSHOHOCKEN, PA 19428
DEVICE: HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
02 MARKETING GROUP INC 510(k) NO: K991569(TRADITIONAL)
ATTN: LESTER FORD PHONE NO : 770-663-3090
11285 ELKINS RD SE DECISION MADE: 03-AUG-99
SUITE H5 510(k) STATEMENT
ROSWELL, GA 30076
DEVICE: 3M LVR SYSTEM
3M CO. 510(k) NO: K991961(TRADITIONAL)
ATTN: LAEL J PICKETT PHONE NO : 651-733-3594
3M CENTER BUILDING 26O-2B-12 SE DECISION MADE: 09-AUG-99
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
A.P. TOTAL CARE, INC. 510(k) NO: K991664(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 19-AUG-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
A.P. TOTAL CARE, INC. 510(k) NO: K991665(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 10-AUG-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03,
A.P. TOTAL CARE, INC. 510(k) NO: K991866(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 02-AUG-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
A.P. TOTAL CARE, INC. 510(k) NO: K991867(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-906-7800
70 HAWLEY AVE, SE DECISION MADE: 02-AUG-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: AB2 MED-FLO SOLUTION SET
AB2 MEDICAL PRODUCTS, LLP 510(k) NO: K984569(TRADITIONAL)
ATTN: ARTHUR CHANDLER,III PHONE NO : 281-362-0130
52 BUTTONBUSH CT SE DECISION MADE: 12-AUG-99
THE WOODLANDS, TX 510(k) STATEMENT
DEVICE: PICCOLO METLYTE 7 REAGENT DISC
ABAXIS INC. 510(k) NO: K992140(TRADITIONAL)
ATTN: LISA MCGRATH PHONE NO : 408-745-6880
1320 CHESAPEAKE TERRACE SE DECISION MADE: 26-AUG-99
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
ABX DIAGNOSTICS, INC. 510(k) NO: K991839(TRADITIONAL)
ATTN: PAT AMTOWER PHONE NO : 949-489-3913
7777 CENTER AVENUE SE DECISION MADE: 11-AUG-99
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
HUNTINGTON BEACH, CA 92647
DEVICE: ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
ACRYMED, INC. 510(k) NO: K992032(TRADITIONAL)
ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830
12232 S.W. GARDEN PL. SE DECISION MADE: 19-AUG-99
PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
ACUSON CORP. 510(k) NO: K991805(TRADITIONAL)
ATTN: WILLIAM WELCH PHONE NO : 650-943-7286
1220 CHARLESTON RD. SE DECISION MADE: 02-AUG-99
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K992470(TRADITIONAL)
ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602
P.O. BOX 3003 SE DECISION MADE: 23-AUG-99
BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIFLO SPACER
AEROMAX TECHNOLOGIES, INC. 510(k) NO: K984085(TRADITIONAL)
ATTN: ALLAN M WACHTER PHONE NO : 602-785-8000
12020 S. WARNER/ELLIOT LOOP SE DECISION MADE: 05-AUG-99
SUITE 124 510(k) STATEMENT
PHOENIX, AZ 85044
DEVICE: ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
AIRSEP CORP. 510(k) NO: K992283(TRADITIONAL)
ATTN: GREG DZIOMBA PHONE NO : 716-691-0202
290 CREEKSIDE DR. SE DECISION MADE: 27-AUG-99
BUFFALO, NY 14228-2070 510(k) STATEMENT
DEVICE: BIOSHIELD EXPRESS STERILIZATION WRAP
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K983719(TRADITIONAL)
ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636
1500 WAUKEGAN RD. SE DECISION MADE: 25-AUG-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERTORS BREATHABLE SURGICAL GOWNS
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K992514(SPECIAL)
ATTN: SHARON ROBBINS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 12-AUG-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE
ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K991981(TRADITIONAL)
ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235
PERINDUSTRIAN BUKIT PANCHOR SE DECISION MADE: 05-AUG-99
14300 NIBONG TEBAL 510(k) STATEMENT
PULAU PINANG, MALAYSIA 52446-U
DEVICE: ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K992663(TRADITIONAL)
ATTN: CHRIS BOHL PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 24-AUG-99
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEPTUNE WASTE MANAGEMENT SYSTEM
AMERICAN IMMUNO TECH 510(k) NO: K990037(TRADITIONAL)
ATTN: ESTHER SALTZ PHONE NO : 949-830-4235
320 KALMUS DRIVE SE DECISION MADE: 24-AUG-99
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETALGARD 3000 FETAL MONITOR
ANALOGIC CORP. 510(k) NO: K983395(TRADITIONAL)
ATTN: STEVEN CLARKE PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 12-AUG-99
PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPLIED BIOTECH SURESTEP HCG/COMBO (II) PREGNANCY TEST
APPLIED BIOTECH, INC. 510(k) NO: K992187(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 619-587-6771
10237 FLANDERS CT. SE DECISION MADE: 04-AUG-99
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: THERMOFLEX SYSTEM
ARGOMED, INC. 510(k) NO: K991847(TRADITIONAL)
ATTN: RICHARD B KLEIN PHONE NO : 919-469-2340
3800 GATEWAY CENTER BLVD SE DECISION MADE: 26-AUG-99
MORRISVILLE, NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX MENISCAL DART SYSTEM
ARTHREX, INC. 510(k) NO: K983577(TRADITIONAL)
ATTN: SCOTT M DURLACHER PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 13-AUG-99
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTA GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K992441(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 20-AUG-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: ADVANTA GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K992443(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 20-AUG-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: JOBST READY-TO-WEAR ARM SLEEVES
BEIERSDORF-JOBT, INC. 510(k) NO: K991570(TRADITIONAL)
ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 20-AUG-99
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
BELMONT INSTRUMENT CORP. 510(k) NO: K992672(SPECIAL)
ATTN: URAIWAN LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 24-AUG-99
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-RX EXTENSION SETS
BENLAN INC. 510(k) NO: K990777(TRADITIONAL)
ATTN: BILL C.K. LIM PHONE NO : 905 829 5004
2760 BRIGHTON RD. SE DECISION MADE: 25-AUG-99
OAKVILLE, ONTARIO, CANADA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-
BERTEC CORP. 510(k) NO: K991642(ABBREVIATED)
ATTN: DOUG MORR PHONE NO : 614-430-5421
6185 HUNTLY ROAD SE DECISION MADE: 03-AUG-99
SUITE B 510(k) STATEMENT
WORTHINGTON, OH 43229
DEVICE: BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TES
BINAX, INC. 510(k) NO: K991726(TRADITIONAL)
ATTN: PAMELA S ANGELL PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 27-AUG-99
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
BIO-RAD LABORATORIES, INC. 510(k) NO: K992550(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 11-AUG-99
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL "LX"
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K990230(ABBREVIATED)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
2448 CADES WAY SE DECISION MADE: 19-AUG-99
VISTA, CA 92083 510(k) STATEMENT
DEVICE: BIPOLAR SHOULDER PROSTHESIS
BIOMET, INC. 510(k) NO: K991585()
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 18-AUG-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MAXIM REMOVABLE MOLDED POLY TIBIA
BIOMET, INC. 510(k) NO: K991753(TRADITIONAL)
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 17-AUG-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LACTOSORB SHEETS
BIOMET, INC. 510(k) NO: K992158(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 20-AUG-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ANATOMICAL BANKART TACK, MODEL 523520A
BIONX IMPLANTS, LTD. 510(k) NO: K992567(SPECIAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 27-AUG-99
HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: STREP B OIA
BIOSTAR, INC. 510(k) NO: K991828(TRADITIONAL)
ATTN: ROGER C BRIDEN PHONE NO : 303-530-3888
6655 LOOKOUT RD. SE DECISION MADE: 19-AUG-99
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POST CEMENT HI-X
BISCO, INC. 510(k) NO: K992248(TRADITIONAL)
ATTN: KATHRYN B PATTERSON PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 25-AUG-99
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
BOSTON SCIENTIFIC/SCIMED 510(k) NO: K992123(TRADITIONAL)
ATTN: MELANIE RASKA PHONE NO : 800-553-5878
ONE SCIEMD PLACE SE DECISION MADE: 23-AUG-99
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO F
BUFFALO FILTER CO., INC. 510(k) NO: K983298(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR. PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 16-AUG-99
BUFFALO, NY 14226 510(k) STATEMENT
DEVICE: BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
BUFFALO FILTER CO., INC. 510(k) NO: K983333(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 11-AUG-99
BUFFALO, NY 14226 510(k) STATEMENT
DEVICE: BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
BUFFALO FILTER CO., INC. 510(k) NO: K983364(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR. PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9 SE DECISION MADE: 11-AUG-99
BUFFALO, NY 14226 510(k) STATEMENT
DEVICE: CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY
CANTOR & SILVER LTD. 510(k) NO: K992500(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 18-AUG-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARD GUARD, MODEL CG-6550
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K990478(TRADITIONAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PEKERIS STREET SE DECISION MADE: 31-AUG-99
REHOVOT, ISRAEL 510(k) STATEMENT
DEVICE: TELEMEDICINE 2000
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K992164(SPECIAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 899 484600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 30-AUG-99
REHOVOT, ISRAEL 76100 510(k) STATEMENT
DEVICE: CARESIDE AMMONIA
CARESIDE, INC. 510(k) NO: K991371(TRADITIONAL)
ATTN: KENNETH B ASSARCH, PHARM PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 03-AUG-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE MG
CARESIDE, INC. 510(k) NO: K991717(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 10-AUG-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
CENOGENICS CORP. 510(k) NO: K992397(TRADITIONAL)
ATTN: NITZA KATZ PHONE NO : 732-536-6457
100 RT. 520 SE DECISION MADE: 26-AUG-99
MORGANVILLE, NJ 07751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
CHARTER MEDICAL, LTD. 510(k) NO: K990310(TRADITIONAL)
ATTN: DAVID HEAGLE PHONE NO : 732-901-9400
1805 SWARTHMORE AVE. SE DECISION MADE: 30-AUG-99
LAKEWOOD, NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
CHEMICON INTL., INC. 510(k) NO: K992252(SPECIAL)
ATTN: CINDY PENNY PHONE NO : 909-676-8080
28835 SINGLE OAK DRIVE SE DECISION MADE: 10-AUG-99
TEMECULA, CA 92590 510(k) STATEMENT
DEVICE: CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
CHIRON DIAGNOSTICS CORP. 510(k) NO: K992157(TRADITIONAL)
ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825
63 NORTH ST. SE DECISION MADE: 05-AUG-99
MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAILIES (NELFILCON A) ONE-DAY
CIBA VISION JOHNS CREEK MFG. 510(k) NO: K992446(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 18-AUG-99
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
CIRCON CORP. 510(k) NO: K992126(TRADITIONAL)
ATTN: RONALD J EHMSEN PHONE NO : 805-961-3290
6500 HOLLISTER AVENUE SE DECISION MADE: 03-AUG-99
SANTA BARBARA, CA 93117-3019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF,
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K992152(TRADITIONAL)
ATTN: J. WILLIAM JONES PHONE NO : 319-656-4447
102 FIRST ST. SOUTH SE DECISION MADE: 17-AUG-99
KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K991890(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 09-AUG-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
COGENT DIAGNOTICS LTD. 510(k) NO: K991942(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK SE DECISION MADE: 24-AUG-99
BUSH LOAN 510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL
DEVICE: COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
COLORSOFT LABORATORIES CORP. 510(k) NO: K992339(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 16-AUG-99
GRANT JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
CONWAY STUART MEDICAL, INC. 510(k) NO: K990724(TRADITIONAL)
ATTN: THOMAS WEHMAN PHONE NO : 408-733-9910
735 PALOMAR ST. SE DECISION MADE: 13-AUG-99
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: URETHANE PICC LINE MODEL UPICS-
COOK, INC. 510(k) NO: K992198(SPECIAL)
ATTN: LISA WEBB PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE SE DECISION MADE: 27-AUG-99
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSOR
CORDIS CORP. 510(k) NO: K991028(TRADITIONAL)
ATTN: CHARLES J RYAN PHONE NO : 908-412-7446
40 TECHNOLOGY DRIVE SE DECISION MADE: 04-AUG-99
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY
CORDIS CORP. 510(k) NO: K991674(TRADITIONAL)
ATTN: CHARLES J RYAN PHONE NO : 908-412-7446
40 TECHNOLOGY DR. SE DECISION MADE: 12-AUG-99
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K984214(TRADITIONAL)
ATTN: ALINA CARABALLO PHONE NO : 305-512-6518
14000 N.W. 57TH CT. SE DECISION MADE: 10-AUG-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX STFR REAGENT
DADE BEHRING, INC. 510(k) NO: K991157(TRADITIONAL)
ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073
GLASGOW SITE SE DECISION MADE: 02-AUG-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: TRIP TONOMETRY CATHETER, 8F
DATEX-OHMEDA, INC. 510(k) NO: K992181(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 978-640-0460
TEWKSBURY, MA 01876 510(k) STATEMENT
DEVICE: DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
DENTSPLY INTL. 510(k) NO: K991909(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 20-AUG-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
DENTSPLY INTL. 510(k) NO: K992516(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 27-AUG-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
DERMAPHYLYX, INC. 510(k) NO: K991920(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 12-AUG-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POCKIT HSV 2 RAPI D TEST
DIAGNOLOGY LTD. 510(k) NO: K983886(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 19-AUG-99
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAMED PARAFFIN WARMER
DIVI INTL. CO. 510(k) NO: K991427(TRADITIONAL)
ATTN: MIKE VIDAL PHONE NO : 305-253-9200
12188 S.W. 128TH ST. SE DECISION MADE: 13-AUG-99
MIAMI, FL 33186 510(k) STATEMENT
DEVICE: ATC OPTION FOR EVITA 2 DURA AND EVITA 4
DRAGER, INC. 510(k) NO: K992608(SPECIAL)
ATTN: HARALD KNEUER PHONE NO : 215-721-6910
3136 QUARRY RD. SE DECISION MADE: 24-AUG-99
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUTECK DIGITAL CLINICAL THERMOMETER
DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K992327(TRADITIONAL)
ATTN: ALLEN REICH PHONE NO : 520-773-9488
900 N. SWITZER DR. #142 SE DECISION MADE: 18-AUG-99
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI OMEGA 21 SYSTEM
EBI ELECTRO BIOLOGY 510(k) NO: K991721(TRADITIONAL)
ATTN: JONAS WILF PHONE NO : 973-299-9022
100 INTERPACE PARKWAY SE DECISION MADE: 13-AUG-99
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS OPTIROM ELBOW FIXATOR
EBI, L.P. 510(k) NO: K992515(SPECIAL)
ATTN: JONAS WILF PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 17-AUG-99
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERMITTENT COMPRESSION BOOT FOR OTC
EISCHOCO, INC. 510(k) NO: K991921(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-582-6470
1232 S.E. 282ND AVENUE SE DECISION MADE: 13-AUG-99
GRESHAM, OR 97080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAWELL OR DYNAWELL
EKEROTH QUALITY AB 510(k) NO: K992120(TRADITIONAL)
ATTN: NILS EKEROTH PHONE NO :
NYBROKAJEN 7 SE DECISION MADE: 13-AUG-99
STOCKHOLM, SWEDEN 102 41 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KI
ELAN DIAGNOSTICS 510(k) NO: K992029(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 12-AUG-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS RAIL SYSTEM
ELECTRO-BIOLOGY, INC. 510(k) NO: K991941(TRADITIONAL)
ATTN: JONAS WILF PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 19-AUG-99
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
ELGEMS, LTD. 510(k) NO: K991841(TRADITIONAL)
ATTN: DAN LAOR PHONE NO : 972 485 63666
P.O. BOX 170 SE DECISION MADE: 26-AUG-99
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANG
ELGEMS, LTD. 510(k) NO: K991896(TRADITIONAL)
ATTN: LAOR DAN PHONE NO : 972 483 10335
P.O. BOX 170 SE DECISION MADE: 23-AUG-99
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMAX ANKLE FUSION ROD SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991790(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 06-AUG-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMAX HAIG II NAIL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K991889(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 12-AUG-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE FULLY COATED HIP
ENCORE ORTHOPEDICS, INC. 510(k) NO: K992109(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 12-AUG-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC SPINAL ACCESS SYSTEM
ENDIUS INC. 510(k) NO: K991794(TRADITIONAL)
ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 13-AUG-99
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSONICS TRAK BACK DEVICE
ENDOSONICS CORP. 510(k) NO: K990271(TRADITIONAL)
ATTN: RICHARD HEBERT PHONE NO : 916-638-8008
2870 KILGORE RD. SE DECISION MADE: 30-AUG-99
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
ESC MEDICAL SYSTEMS, INC. 510(k) NO: K991628(TRADITIONAL)
ATTN: ZVI LADIN PHONE NO : 972 495 99000
YOKNEAM INDUSTRIAL PARK SE DECISION MADE: 09-AUG-99
PO BOX 240 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692
DEVICE: MODIFICATION OF PROMPT L-POP
ESPE DENTAL AG 510(k) NO: K992048(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 16-AUG-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAN
ETHICON ENDO-SURGERY, INC. 510(k) NO: K991980(TRADITIONAL)
ATTN: TAMIMA ITANI PHONE NO : 513-483-8205
4545 CREEK RD. SE DECISION MADE: 17-AUG-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
EUROMED, INC. 510(k) NO: K992363(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 12-AUG-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
EXCEL TECH. LTD. 510(k) NO: K991903(TRADITIONAL)
ATTN: JOHN R MUMFORD PHONE NO : 905 829 5300
2892 PORTLAND DR. SE DECISION MADE: 04-AUG-99
OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT
DEVICE: XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
EXCEL TECH. LTD. 510(k) NO: K992313(TRADITIONAL)
ATTN: JOHN R MUMFORD PHONE NO : 905 829 5300
2892 PORTLAND DR. SE DECISION MADE: 19-AUG-99
OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT
DEVICE: FERRIS POLYOSTOMY STERILE WOUND DRESSING
FERRIS MFG. CORP. 510(k) NO: K991729(TRADITIONAL)
ATTN: THEODORE THORSEN PHONE NO : 630-887-9797
16 WEST 300 83RD ST. SE DECISION MADE: 27-AUG-99
BURR RIDGE, IL 60521 510(k) STATEMENT
DEVICE: FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K992040(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 06-AUG-99
NEWTON, MA 02468 510(k) STATEMENT
DEVICE: FOTONA NOVALIS ER: YAG LASER SYSTEM
FOTONA D.D. 510(k) NO: K991632(TRADITIONAL)
ATTN: MOJCA VALIJAVEC PHONE NO : 386 611 511215
STEGNE 7, SE DECISION MADE: 10-AUG-99
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA NOVALIS R RUBY LASER SYSTEM
FOTONA D.D. 510(k) NO: K991634(TRADITIONAL)
ATTN: MOJCA VALIJAVEC PHONE NO : 386 611 511215
STEGNE 7, SE DECISION MADE: 10-AUG-99
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODI
FRESENIUS USA, INC. 510(k) NO: K992275(SPECIAL)
ATTN: VIRGINIA SINGER PHONE NO : 925-688-0990
110 MASON CR SE DECISION MADE: 04-AUG-99
CONCORD, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FURLONG INDUSTRIES 510(k) NO: K991757(TRADITIONAL)
ATTN: PETE FURLONG PHONE NO : 847-548-6831
311 N. SLUSSER STREET SE DECISION MADE: 12-AUG-99
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
GALLINI U.S., LLC 510(k) NO: K992499(TRADITIONAL)
ATTN: PAUL L HAWTHORNE PHONE NO : 800-281-0908
3991 GLENSIDE DR., SUITE F SE DECISION MADE: 12-AUG-99
RICHMOND, VA 23229 510(k) STATEMENT
DEVICE: CHOLESITE TEST SYSTEM
GDS TECHNOLOGY, INC. 510(k) NO: K992132(TRADITIONAL)
ATTN: KEITH CRAWFORD PHONE NO : 219-264-7384
25235 LEER DR. SE DECISION MADE: 20-AUG-99
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991735(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 19-AUG-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991739(TRADITIONAL)
ATTN: MARIA VITUG FOUTS PHONE NO : 800-851-6525
200 HARRY S. TRUMAN, PARKWAY SE DECISION MADE: 19-AUG-99
SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA
ANNAPOLIS, MD 21401
DEVICE: GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EX
GE MEDICAL SYSTEMS, INC. 510(k) NO: K991629(TRADITIONAL)
ATTN: LARRY KROGER PHONE NO : 414-544-3894
P.O. BOX 414 SE DECISION MADE: 02-AUG-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K992149(TRADITIONAL)
ATTN: JOHN BOTTJER PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 19-AUG-99
MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K992066(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
3000 N GRANDVIEW BLVD SE DECISION MADE: 30-AUG-99
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
GENERAL GLOVES CORP. 510(k) NO: K992107(TRADITIONAL)
ATTN: DAVID HU PHONE NO : 510-732-9623
3423 INVESTMENT BLVD SE DECISION MADE: 23-AUG-99
SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94545
DEVICE: GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
GENTELL 510(k) NO: K990440(TRADITIONAL)
ATTN: MARK L ITZKOFF PHONE NO : 202-776-7800
1667 K ST. N.W., SUITE 700 SE DECISION MADE: 12-AUG-99
WASHINGTON, DC 20006-1608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSONIC 2000
GREEN RIVER, INC. 510(k) NO: K990545(TRADITIONAL)
ATTN: CESAR CORAL PHONE NO : 954-733-4300
5101 N.W. 21ST AVE., SUITE 141 SE DECISION MADE: 11-AUG-99
FORT LAUDERDALE, FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KANGNIAN BRAND ACUPUNCTURE NEEDLE
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K991507(TRADITIONAL)
ATTN: YI-FEN CHANG PHONE NO : 408-748-9585
2080A WALSH AVE. SE DECISION MADE: 27-AUG-99
SANTA CLARA, CA 95050 510(k) STATEMENT
DEVICE: ACUMASTER BRAND ACUPUNCTURE NEEDLE
HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K991508(TRADITIONAL)
ATTN: YI-FEN CHANG PHONE NO : 408-748-9585
2080A WALSH AVE. SE DECISION MADE: 27-AUG-99
SANTA CLARA, CA 95050 510(k) STATEMENT
DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992224(TRADITIONAL)
ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766
40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992241(TRADITIONAL)
ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766
40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K992243(TRADITIONAL)
ATTN: JOSEPH M CALIFANO PHONE NO : 781-890-3766
40 BEAR HILL ROAD SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT
HEMOCLEANSE, INC. 510(k) NO: K984546(TRADITIONAL)
ATTN: STEPHEN R ASH PHONE NO : 765-463-9540
2700 KENT AVE. SE DECISION MADE: 13-AUG-99
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M350
HEWLETT-PACKARD CO. 510(k) NO: K991871(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 05-AUG-99
DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
HEWLETT-PACKARD CO. 510(k) NO: K992636(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 31-AUG-99
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K991055(TRADITIONAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376
59 ROUTE 17 SE DECISION MADE: 27-AUG-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992025(TRADITIONAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376
59 ROUTE 17 SE DECISION MADE: 13-AUG-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KINEMATIC II ROTATING HINGE KNEE
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992346(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 12-AUG-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992462(TRADITIONAL)
ATTN: KATE SUTTON PHONE NO : 201-934-4386
59 ROUTE 17 SE DECISION MADE: 13-AUG-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY-CURE (CURING AND WHITENING LIGHT)
ICS OF NORTH AMERICA, INC. 510(k) NO: K992357(TRADITIONAL)
ATTN: ALAN A CREAMER PHONE NO : 619-558-9203
10054 MESA RIDGE CT. SE DECISION MADE: 30-AUG-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOTE INTRODUCER, MODEL PI-1000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K990907(TRADITIONAL)
ATTN: MICHAEL J RENNER PHONE NO : 407-757-8990
2290 EAU GALLIE BLVD SE DECISION MADE: 12-AUG-99
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K992304(TRADITIONAL)
ATTN: MICHAEL J RENNER PHONE NO : 407-757-8990
2290 EAU GALLIE BLVD. SE DECISION MADE: 27-AUG-99
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
INDUS MEDICARE LTD. 510(k) NO: K992438(ABBREVIATED)
ATTN: P.K. REDDY PHONE NO : 91 407 760241
144, S.P. RD., BEGUMPET SE DECISION MADE: 02-AUG-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT
DEVICE: REPOSE BONE SCREW SYSTEM
INFLUENCE, INC. 510(k) NO: K981677(TRADITIONAL)
ATTN: JONATHAN S KAHAN, ESQ. PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 27-AUG-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
INFLUENCE, INC. 510(k) NO: K991792(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 12-AUG-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNERDYNE RADIALLY EXPANDING DILATION, "RED" DEVICE
INNERDYNE, INC. 510(k) NO: K990854(TRADITIONAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-350-3600
5060 WEST AMELIA EARHART DR. SE DECISION MADE: 02-AUG-99
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACMED PAEDIATRIC INTRAMEDULLARY NAIL
INNERVISION, INC. 510(k) NO: K991877(TRADITIONAL)
ATTN: FRANK M LEWIS PHONE NO : 901-682-0417
6258 SHADY GROVE RD. EAST SE DECISION MADE: 06-AUG-99
MEMPHIS, TN 38120 510(k) STATEMENT
DEVICE: CAPHOSOL ARTIFICIAL SALIVA
INPHARMA A.S. 510(k) NO: K991938(TRADITIONAL)
ATTN: BRUCE R MANNING PHONE NO : 508-393-3100
P.O. BOX 809, 27 SOUTH STREET SE DECISION MADE: 10-AUG-99
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTOSNARE
INSCOPE, LLC 510(k) NO: K992477(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 24-AUG-99
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VEN
INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K991785(TRADITIONAL)
ATTN: TRICIA WOOD PHONE NO : 412-854-1133
2990 INDUSTRIAL BLVD. SE DECISION MADE: 17-AUG-99
BETHEL PARK, PA 15102 510(k) STATEMENT
DEVICE: TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,S
INSTRUMENTS FOR MEDICINE AND DIAGN510(k) NO: K992508(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-972-0500
3959 WEST 1820 SOUTH SE DECISION MADE: 19-AUG-99
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
INTEGRA NEUROCARE LLC 510(k) NO: K992006(TRADITIONAL)
ATTN: NANCY A MATHEWSON PHONE NO : 858-455-1115
5955 PACIFIC CENTER BLVD. SE DECISION MADE: 17-AUG-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOPLAST, MODEL POP200
INTERPORE CROSS INTL. 510(k) NO: K991854(TRADITIONAL)
ATTN: LYNN RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 26-AUG-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRASTENT
INTRATHERAPEUTICS, INC. 510(k) NO: K991929(SPECIAL)
ATTN: CATHY YOHNK PHONE NO : 612-697-2003
651 CAMPUS DR. SE DECISION MADE: 04-AUG-99
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
INTRAVASCULAR RESEARCH LTD. 510(k) NO: K982208(TRADITIONAL)
ATTN: LOUISE C MYERS PHONE NO : 425-867-0892
14808 N.E. 66TH STREET SE DECISION MADE: 27-AUG-99
REDMOND, WA 98052-4712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
INVACARE CORP. 510(k) NO: K991119(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
1200 TAYLOR ST. SE DECISION MADE: 19-AUG-99
ELYRIA, OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
INVACARE CORP. 510(k) NO: K992052(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 12-AUG-99
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & L
JAKOUBEK MEDIZINTECHNIK GMBH 510(k) NO: K990785(TRADITIONAL)
ATTN: DOUGLAS HULFISH PHONE NO : 847-670-8293
1822 N. STRATFORD RD. SE DECISION MADE: 27-AUG-99
ARLINGTON HTS., IL 60004 510(k) STATEMENT
DEVICE: JMS A. V. FISTULA NEEDLE SET
JMS CO., LTD. 510(k) NO: K990470(TRADITIONAL)
ATTN: TETSUHARU HIROSE PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 30-AUG-99
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: JMS APHERESIS NEEDLE
JMS CO., LTD. 510(k) NO: K990510(TRADITIONAL)
ATTN: TETSUHARU HIROSE PHONE NO : 81 82 2435806
12-17, KAKO-MACHI, NAKA-KU SE DECISION MADE: 30-AUG-99
HIROSHIMA, JAPAN 730-8652 510(k) STATEMENT
DEVICE: MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
JMS CO., LTD. 510(k) NO: K991904(TRADITIONAL)
ATTN: KEISUKE URATOMI PHONE NO : 818 224 35806
12,17,KAKO-MACHI,NAKA-KU SE DECISION MADE: 31-AUG-99
HIROSHIMA, 730, JAPAN 510(k) STATEMENT
DEVICE: MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS,
JOHNSON & JOHNSON MEDICAL, DIV. OF510(k) NO: K990236(TRADITIONAL)
ATTN: LINDA G HILL PHONE NO : 817-262-4791
2500 EAST ARBROOK BLVD. SE DECISION MADE: 20-AUG-99
ARLINGTON, TX 76014-3631 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA HL-20 TWIN PUMP
JOSTRA USA 510(k) NO: K984338(TRADITIONAL)
ATTN: KATHY JOHNSON PHONE NO : 877-567-8722
478 MEDIA ROAD SE DECISION MADE: 19-AUG-99
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA CALCUSPLIT
KARL STORZ ENDOSCOPY 510(k) NO: K992114(TRADITIONAL)
ATTN: KEVIN A KENNAN PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 18-AUG-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPAROCAM
KARL STORZ ENDOSCOPY 510(k) NO: K992541(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 19-AUG-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
KATECHO, INC. 510(k) NO: K991007(TRADITIONAL)
ATTN: LORNE SCHARNBERG PHONE NO : 515-244-1212
2500 BELL AVE. SE DECISION MADE: 23-AUG-99
DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL VIDEO RECORDING SYSTEM
KAY ELEMETRICS CORP. 510(k) NO: K991738(TRADITIONAL)
ATTN: WILLIAM D HARBESON PHONE NO : 973-628-6200
2 BRIDGEWATER LN. SE DECISION MADE: 13-AUG-99
LINCOLN PARK, NJ 07035-1488 510(k) STATEMENT
DEVICE: KELLER VITAL SIGNS MONITOR, KMS 890+
KELLER MEDICAL SPECIALTIES PRODUCT510(k) NO: K990648(TRADITIONAL)
ATTN: JEAN WAGNER PHONE NO : 847-395-3547
42609 CRAWFORD RD SE DECISION MADE: 10-AUG-99
ANTIOCH, IL 60002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLAZE
KERR DENTAL MATERIALS CENTER 510(k) NO: K992067(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 27-AUG-99
ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
KIEL LABORATORIES, INC. 510(k) NO: K991958(TRADITIONAL)
ATTN: TANYJA PORCHA PHONE NO : 770-534-0079
2225 CENTENNIAL DRIVE SE DECISION MADE: 13-AUG-99
GAINESVILLE, GA 30504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMI WRIST FUSION SYSTEM
KINETIKOS MEDICAL, INC. 510(k) NO: K991873(TRADITIONAL)
ATTN: MICHAEL COLLINS PHONE NO : 619-558-2233
4115 SORRENTO VALLEY BLVD. SE DECISION MADE: 17-AUG-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-L-W INTRAORAL DISTRACTOR
KLS-MARTIN L.P. 510(k) NO: K991875(TRADITIONAL)
ATTN: ED RANSOM PHONE NO : 813-376-4154
3234 ELLA LANE SE DECISION MADE: 18-AUG-99
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICA DIRECT DIGITIZER, MODEL DD-341
KONICA CORP. 510(k) NO: K990359(TRADITIONAL)
ATTN: RUSSELL D MUNVES PHONE NO : 212-490-4100
THE CHRYSLER BUILDING SE DECISION MADE: 17-AUG-99
405 LEXINGTON AVENUE 510(k) STATEMENT
NEW YORK, NY 10174
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORE
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992496(TRADITIONAL)
ATTN: LIM KWAN HWA PHONE NO : 603 392 7616
LOT 16632, 5-1/4 MILES, SE DECISION MADE: 25-AUG-99
JALAN MERU 510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050
DEVICE: POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992497(TRADITIONAL)
ATTN: LIM KWAN HWA PHONE NO : 603 392 7616
LOT 16632, 5-1/4 MILES, SE DECISION MADE: 25-AUG-99
JALAN MERU 510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050
DEVICE: KRONUS OPTIQUANT THYROGLOBULIN KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K991720(TRADITIONAL)
ATTN: A.P. DOERSCCHUK PHONE NO : 800-822-6999
1000 CALLE AMANECER SE DECISION MADE: 09-AUG-99
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: THERADYNE ROVER POWERED WHEELCHAIR
KURT MFG. CO. 510(k) NO: K982724(ABBREVIATED)
ATTN: PHIL SCHLANGEN PHONE NO : 612-623-4047
1325 QUINCY STREET N.E. SE DECISION MADE: 12-AUG-99
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROSTYM BIOFEEDBACK AND STIMULATION PROBES
LABORIE MEDICAL TECH CORP. 510(k) NO: K990041(TRADITIONAL)
ATTN: DALE COLEMAN PHONE NO : 802-878-1110
310 HURRICANE LANE #2 SE DECISION MADE: 05-AUG-99
WILLISTON, VT 05495 510(k) STATEMENT
DEVICE: LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
LAGLOVE (M) SDN. BHD. 510(k) NO: K990883(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5054
JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 10-AUG-99
13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR
DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
LAGLOVE (M) SDN. BHD. 510(k) NO: K991949(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5054
JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 12-AUG-99
13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR
DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
LAGLOVE (M) SDN. BHD. 510(k) NO: K991950(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 35411
JALAN SIMPANG BALAK, OFF BATU SE DECISION MADE: 12-AUG-99
13, JALAN CHERAS, 43000 KAJANG 510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR
DEVICE: LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT L
LAGLOVE (M) SDN. BHD. 510(k) NO: K992019(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 05-AUG-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: PARAGON
LANCER ORTHODONTICS, INC. 510(k) NO: K991481(TRADITIONAL)
ATTN: DOUGLAS D MILLER PHONE NO : 760-744-5585
253 PAWNEE ST. SE DECISION MADE: 11-AUG-99
SAN MARCOS, CA 92069 510(k) STATEMENT
DEVICE: LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGUR
LASERSCOPE 510(k) NO: K990903(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 408-943-0636
3052 ORCHARD DR. SE DECISION MADE: 27-AUG-99
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B2C HIP SYSTEM
LEPINE GROUPE SPA. 510(k) NO: K992490(TRADITIONAL)
ATTN: DOUGLAS W STUART PHONE NO : 941-366-1882
962 SOUTH TAMIAMI, STE. 203 SE DECISION MADE: 19-AUG-99
SARASOTA, FL 34326 510(k) STATEMENT
DEVICE: SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
LIBRARY MEDICAL INC. 510(k) NO: K991312(TRADITIONAL)
ATTN: RICHARD A HARTMAN PHONE NO : 800-711-8055
60 TERENCE DR. SE DECISION MADE: 20-AUG-99
PITTSBURGH, PA 15236 510(k) STATEMENT
DEVICE: TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVOR
LINE ONE LABORATORIES 510(k) NO: K991892(TRADITIONAL)
ATTN: ROBERT GRUBER PHONE NO : 323-264-8887
1481 EAST 4TH ST. SE DECISION MADE: 19-AUG-99
LOS ANGELES, CA 90033 510(k) STATEMENT
DEVICE: BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
LINVATEC CORP. 510(k) NO: K991715(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 06-AUG-99
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSULAR SHRINKAGE ELECTRODE
LINVATEC CORP. 510(k) NO: K991830(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-392-6464
11311 CONCEPT BLVD. SE DECISION MADE: 20-AUG-99
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMA LIGHT 2000 CURE LIGHT
LUMA LITE, INC, 510(k) NO: K992102(TRADITIONAL)
ATTN: JOSEPH FOREHAND PHONE NO : 619-318-1251
477 MARINA PARKWAY #400 SE DECISION MADE: 31-AUG-99
CHULA VISTA, CA 91910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUET II GLUCOSE CONTROL MONITORING SYSTEM
LXN CORP. 510(k) NO: K990942(TRADITIONAL)
ATTN: NEDA RASHTI PHONE NO : 619-546-7500
6325 LUSK BLVD. SE DECISION MADE: 02-AUG-99
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000
LYSTA A/S 510(k) NO: K992236(TRADITIONAL)
ATTN: GREGERS LYSTAGER PHONE NO : 454 495 3000
GAMMELGAARDSVEJ 102 SE DECISION MADE: 27-AUG-99
FARUM, DENMARK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNATEK 30
MAGNA ADVANCED TECHNOLOGIES, INC. 510(k) NO: K991819(TRADITIONAL)
ATTN: ANNIE VELEZ PHONE NO : 305-261-2211
7200 N.W. SEVENTH STREET SE DECISION MADE: 19-AUG-99
MIAMI, FL 33126 510(k) STATEMENT
DEVICE: MAHE INSTRUMENTS
MAHE INTL., INC. 510(k) NO: K991426(TRADITIONAL)
ATTN: WINIFRIED REICH PHONE NO : 615-385-3545
300 JAMES ROBERTSON PKWY. SE DECISION MADE: 05-AUG-99
NASHVILLE, TN 37201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL WHEELCHAIR
MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K992035(TRADITIONAL)
ATTN: SCOTT SCHWEISS PHONE NO : 281-398-5444
18206 MANCE CT. SE DECISION MADE: 12-AUG-99
HOUSTON, TX 77094 510(k) STATEMENT
DEVICE: HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
MEDIC-AID LTD. 510(k) NO: K991685(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 13-AUG-99
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
MEDICAL ADVANCES, INC. 510(k) NO: K991724(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 02-AUG-99
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K992430(TRADITIONAL)
ATTN: SCOT D KINGHORN PHONE NO : 800-582-3095
542 FLYNN RD. SE DECISION MADE: 30-AUG-99
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K992411(SPECIAL)
ATTN: DAVID M TRUEBLOOD PHONE NO : 818-768-6411
12720 WENTWORTH ST. SE DECISION MADE: 18-AUG-99
ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K992413(SPECIAL)
ATTN: DAVID M TRUEBLOOD PHONE NO : 818-768-6411
12720 WENTWORTH ST. SE DECISION MADE: 19-AUG-99
ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIFIX INC.
MEDIFIX INC. 510(k) NO: K992483(TRADITIONAL)
ATTN: GEORGE ALBULESCU PHONE NO : 847-965-1898
8727 NARRAGANSETT SE DECISION MADE: 30-AUG-99
MORTON GROVE, IL 60053-0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SE
MEDIMEX HOLFELD GMBH & CO. 510(k) NO: K991719(TRADITIONAL)
ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075
MID VALLEY PROFESSIONAL PLAZA SE DECISION MADE: 18-AUG-99
SALT LAKE CITY, UT 84047-7101 510(k) STATEMENT
DEVICE: MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
MEDLINE INDUSTRIES, INC. 510(k) NO: K991559(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-949-2639
ONE MEDLINE PL. SE DECISION MADE: 23-AUG-99
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: MEDTRONIC AVE BRIDGE STENT
MEDTRONIC AVE, INC. 510(k) NO: K992318(SPECIAL)
ATTN: SUSAN WALTON PHONE NO : 707-591-7315
2330A CIRCADIAN WAY SE DECISION MADE: 02-AUG-99
SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC AVE BRIDGE STENT
MEDTRONIC AVE, INC. 510(k) NO: K992569(SPECIAL)
ATTN: SUSAN WALTON PHONE NO : 707-591-7315
2330A CIRCADIAN WAY SE DECISION MADE: 31-AUG-99
SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARD STAT! E. COLI O157:H7
MERIDIAN DIAGNOSTICS, INC. 510(k) NO: K990263(TRADITIONAL)
ATTN: ALLEN D NICKOL PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 09-AUG-99
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
METRIKA, INC. 510(k) NO: K984530(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
575 SHIRLYNN COURT SE DECISION MADE: 10-AUG-99
LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
MICRO MOTORS, INC. 510(k) NO: K991283(TRADITIONAL)
ATTN: KAREN U SALINAS PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 18-AUG-99
IRVINE, CA 92606-1849 510(k) STATEMENT
DEVICE: EQUINOX OCCLUSION BALLOON SYSTEM
MICRO THERAPEUTICS, INC. 510(k) NO: K990487(TRADITIONAL)
ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 31-AUG-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
MICRODIAGNOSTICS, INC. 510(k) NO: K991505(TRADITIONAL)
ATTN: ROY CHUNG PHONE NO : 714-347-0307
28062 FORBES ROAD, SUITE B SE DECISION MADE: 05-AUG-99
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: MICRO-STRIP FOR MARIJUANA METABOLITES
MICRODIAGNOSTICS, INC. 510(k) NO: K991516(TRADITIONAL)
ATTN: ROY CHUNG PHONE NO : 949-347-0307
28062 FORBES ROAD, SUITE B SE DECISION MADE: 05-AUG-99
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: SILVERSTEIN MICROWICK
MICROMEDICS, INC. 510(k) NO: K991670(TRADITIONAL)
ATTN: CHARLES GROTE PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR., SE DECISION MADE: 26-AUG-99
#150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCES
MICROMEDICS, INC. 510(k) NO: K992138(TRADITIONAL)
ATTN: CHARLES GROTE PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR., SE DECISION MADE: 09-AUG-99
#150 510(k) STATEMENT
EAGAN, MN 55121
DEVICE: RENACLEAR DIALYZER CLEANING SYSTEM
MINNTECH CORP. 510(k) NO: K991851(TRADITIONAL)
ATTN: RICHARD M ORMSBEE PHONE NO : 612-551-2689
14605 28TH AVE. NORTH SE DECISION MADE: 30-AUG-99
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MITAKA POINT SETTER
MITAKA USA, INC. 510(k) NO: K991989(TRADITIONAL)
ATTN: MAX STURGIS PHONE NO : 435-649-2236
2337 LUCKY JOHN DRIVE SE DECISION MADE: 27-AUG-99
PARK CITY, UT 84060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
MITEK PRODUCTS 510(k) NO: K992406(SPECIAL)
ATTN: PAULA E BULGER PHONE NO : 781-251-2746
60 GLACIER DR. SE DECISION MADE: 06-AUG-99
WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORODYN 8000 SEMG SYSTEM, ND-8000
MYOTRONICS-NOROMED, INC. 510(k) NO: K992439(SPECIAL)
ATTN: FRAY ADIB PHONE NO : 206-243-4214
15425 53RD AVE. SOUTH SE DECISION MADE: 13-AUG-99
TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILGEL STC-S
NAGOR LTD. 510(k) NO: K984029(TRADITIONAL)
ATTN: J.A. EVANS PHONE NO : 44 016 24625556
PO BOX 21 DOUGLAS SE DECISION MADE: 05-AUG-99
ISLE OF MAN IM99 1AX 510(k) SUMMARY AVAILABLE FROM FDA
BRITISH ISLES, BRITISH VIRGIN ISLANDS
DEVICE: SUZANNE
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K990565(TRADITIONAL)
ATTN: DARIN BUSCH PHONE NO : 612-694-3563
2800 NORTHWEST BLVD. SE DECISION MADE: 18-AUG-99
MINNEAPOLIS, MN 55441-2625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N-395 PULSE OXIMETER, MODEL N-395
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K991823(TRADITIONAL)
ATTN: DAVID A. C. GREEN PHONE NO : 760-603-5978
2200 FARADAY AVE. SE DECISION MADE: 25-AUG-99
CARLSBAD, CA 92008-7208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTANEOUS (BAR) ELECTRODE
NEURO SUPPLIES, INC. 510(k) NO: K991769(TRADITIONAL)
ATTN: RONALD LUICH PHONE NO : 860-442-5650
86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385 510(k) STATEMENT
DEVICE: CUTANEOUS (GROUND) ELECTRODE
NEURO SUPPLIES, INC. 510(k) NO: K991770(TRADITIONAL)
ATTN: RONALD LUICH PHONE NO : 860-442-5650
86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385 510(k) STATEMENT
DEVICE: DIGITAL RING ELECTRDE
NEURO SUPPLIES, INC. 510(k) NO: K991771(TRADITIONAL)
ATTN: RONALD LUICH PHONE NO : 860-442-5650
86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385 510(k) STATEMENT
DEVICE: CUTANEOUS (DISC) ELECTRODE
NEURO SUPPLIES, INC. 510(k) NO: K991772(TRADITIONAL)
ATTN: RONALD LUICH PHONE NO : 860-442-5650
86 BOSTON POST ROAD SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385 510(k) STATEMENT
DEVICE: SOLUSTAPLE
NEWDEAL S.A. 510(k) NO: K991566(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 03-AUG-99
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
NIDEK, INC. 510(k) NO: K991284(TRADITIONAL)
ATTN: JERRY TSUTSUMI PHONE NO : 510-353-7706
47651 WESTINGHOUSE DR. SE DECISION MADE: 06-AUG-99
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERI
NIPRO MEDICAL CORP. 510(k) NO: K991623(TRADITIONAL)
ATTN: KAELYN HADLEY PHONE NO : 606-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 09-AUG-99
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9
NONIN MEDICAL, INC. 510(k) NO: K982969(TRADITIONAL)
ATTN: RICHARD P BENNETT PHONE NO : 612-553-9968
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 12-AUG-99
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER PORCELAIN TI-22
NORITAKE CO., INC. 510(k) NO: K992024(TRADITIONAL)
ATTN: MARSHA C WERTZBERGER PHONE NO : 202-857-6122
1050 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 27-AUG-99
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: BURNFREE PAIN RELIEVING GEL, MODEL 4B
NORTRADE MEDICAL, INC. 510(k) NO: K990178(TRADITIONAL)
ATTN: JAY W TAYLOR PHONE NO : 801-569-9090
9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99
SANDY, UT 84070 510(k) STATEMENT
DEVICE: BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
NORTRADE MEDICAL, INC. 510(k) NO: K990179(TRADITIONAL)
ATTN: JAY W TAYLOR PHONE NO : 801-569-9090
9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99
SANDY, UT 84070 510(k) STATEMENT
DEVICE: BURNFREE (4"X4", 8"X8", 16"X24") STERILE BURN & WOUND DRESSING
NORTRADE MEDICAL, INC. 510(k) NO: K990180(TRADITIONAL)
ATTN: JAY W TAYLOR PHONE NO : 801-569-9090
9382 SOUTH 670 WEST SE DECISION MADE: 13-AUG-99
SANDY, UT 84070 510(k) STATEMENT
DEVICE: MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD
NSK NAKANISHI, INC. 510(k) NO: K991701(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 10-AUG-99
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: MINI 6800 DIGITAL MOBILE C-ARM
OEC MEDICAL SYSTEMS, INC. 510(k) NO: K992506(ABBREVIATED)
ATTN: TED L PARROT PHONE NO : 801-328-9300
384 WRIGHT BROTHERS DR. SE DECISION MADE: 19-AUG-99
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
OLYMPUS AMERICA, INC. 510(k) NO: K992086(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5415
TWO CORPORATE CENTER DR. SE DECISION MADE: 19-AUG-99
MELVILLE, NY 11042-1179 510(k) STATEMENT
DEVICE: PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-S
OMNIGRACE LTD. 510(k) NO: K991845(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641, MOO5 KANCHANAWANIT ROAD SE DECISION MADE: 05-AUG-99
TAMBON BANPRU 510(k) STATEMENT
HAT YAI, SONGKHLA, THAILAND 90250
DEVICE: PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STE
OMNIGRACE LTD. 510(k) NO: K991846(TRADITIONAL)
ATTN: K.C. CHOONG PHONE NO : 667 443 9526
641, MOO5 KANCHANAWANIT ROAD SE DECISION MADE: 05-AUG-99
TAMBON BANPRU 510(k) STATEMENT
HAT YAI, SONGKHLA, THAILAND 90250
DEVICE: RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A
OPTI-CENTRE LABORATORIES 510(k) NO: K992589(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 26-AUG-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESSEYE
OPTOMOTOR LABORATORIES 510(k) NO: K992473(TRADITIONAL)
ATTN: BURKHART FISCHER PHONE NO : 49 741 2922600
TIVOLISTR. 11 SE DECISION MADE: 12-AUG-99
D-79104 FREIBURG, GERMANY D-79104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOF-WATCH S
ORGANON TEKNIKA CORP. 510(k) NO: K992596(SPECIAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 30-AUG-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOF-WATCH SX
ORGANON TEKNIKA CORP. 510(k) NO: K992598(SPECIAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 30-AUG-99
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K992349(TRADITIONAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 24-AUG-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K991083(TRADITIONAL)
ATTN: JAMES W HARRIS PHONE NO : 301-527-4719
2440 RESEARCH BLVD SE DECISION MADE: 20-AUG-99
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPLORER 3D
OUR SCIENTIFIC INTL., INC. 510(k) NO: K991815(TRADITIONAL)
ATTN: MARIO CABALLERO PHONE NO : 925-227-1998
5870 STONERIDGE DRIVE SE DECISION MADE: 13-AUG-99
PLEASANTVILLE, CA 94588 510(k) STATEMENT
DEVICE: HEPARIN CONTROL PLASMA LEVEL 1
PACIFIC HEMOSTASIS 510(k) NO: K992278(TRADITIONAL)
ATTN: LAURA A WORFOLK PHONE NO : 704-875-0494
11515 VANSTORY DR. SE DECISION MADE: 26-AUG-99
HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN CONTROL PLASMA LEVEL 2
PACIFIC HEMOSTASIS 510(k) NO: K992279(TRADITIONAL)
ATTN: LAURA A WORFOLK PHONE NO : 704-875-0494
11515 VANSTORY DR. SE DECISION MADE: 26-AUG-99
HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF
PALL MEDICAL 510(k) NO: K992361(TRADITIONAL)
ATTN: LEONARD S BERMAN PHONE NO : 516-484-5400
2200 NORTHERN BOULEVARD SE DECISION MADE: 20-AUG-99
EAST HILLS, NY 11548-1209 510(k) STATEMENT
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLO
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992165(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 25-AUG-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION G
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992223(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 30-AUG-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992299(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 23-AUG-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: CERSR ELECTROMYOGRAPHY SYSTEM
PAPASPINAL DIAGNOSTIC CO. 510(k) NO: K990766(TRADITIONAL)
ATTN: JOEL S FADEN PHONE NO : 301-881-9139
11605 HITCHING POST LANE SE DECISION MADE: 27-AUG-99
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLAX TRACER RADIOPAQUE PARTICLES
PARALLAX MEDICAL, INC. 510(k) NO: K991893(TRADITIONAL)
ATTN: SUSAN G MARQUES PHONE NO : 650-934-6969
453 RAVENDALE DR., SUITE B SE DECISION MADE: 13-AUG-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K991925(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST FORTY-SECOND AVENUE SE DECISION MADE: 26-AUG-99
WHEAT RIDGEE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K992059(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 30-AUG-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
PASCO LABORATORIES, INC. 510(k) NO: K992076(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-432-9504
12750 WEST 42ND AVE. SE DECISION MADE: 30-AUG-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUNNEL TROCAR
PATTON MEDICAL CORPORATION 510(k) NO: K992324(TRADITIONAL)
ATTN: MICHAEL T PATTON PHONE NO : 512-329-0469
1000 WESTBANK DRIVE SE DECISION MADE: 19-AUG-99
SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: O.B. TAMPON
PERSONAL PRODUCTS CO. 510(k) NO: K990536(TRADITIONAL)
ATTN: RALPH PETRONE PHONE NO : 908-874-1700
199 GRANDVIEW RD. SE DECISION MADE: 31-AUG-99
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY SHOULDER COIL
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K991765(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7674
710 BRIDGEPORT AVENUE SE DECISION MADE: 02-AUG-99
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0197
DEVICE: MRGP OPTICAL TRACKING UNIT
PICKER INTERNATIONAL, INC. 510(k) NO: K991943(TRADITIONAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER ROAD SE DECISION MADE: 23-AUG-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPASS BOLUS TRACKING
PICKER INTERNATIONAL, INC. 510(k) NO: K992412(SPECIAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 17-AUG-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANMED SOPHIE AND SOPHIE CLASSIC
PLANMED OY 510(k) NO: K991826(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-595-7077
362, BALM COURT SE DECISION MADE: 10-AUG-99
WOOD DALE, IL 60191 510(k) STATEMENT
DEVICE: PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
PLUS ORTHOPEDICS 510(k) NO: K990261(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 619-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 27-AUG-99
SAN DIEGO, CA 92121-1194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOHDL CHOLESTEROL REAGENT SET
POINTE SCIENTIFIC, INC. 510(k) NO: K992002(TRADITIONAL)
ATTN: WILLIAM F WALTERS PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR. SE DECISION MADE: 05-AUG-99
LINCOLN PARK, MI 48146 510(k) STATEMENT
DEVICE: BLULAZE
PREMIER LASER SYSTEMS 510(k) NO: K992620(TRADITIONAL)
ATTN: BETH A ROBERTS PHONE NO : 317-585-8160
3 MORGAN SE DECISION MADE: 20-AUG-99
IRVINE, CA 92718 510(k) STATEMENT
DEVICE: ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/O
PRINCETON BIOMEDITECH CORP. 510(k) NO: K992422(SPECIAL)
ATTN: JEMO KANG PHONE NO : 800-726-2670
4242 U.S. RT. 1 SE DECISION MADE: 10-AUG-99
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: QUICKVUE ONE-STEP H. PYLORI II TEST
QUIDEL CORP. 510(k) NO: K991747(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 619-552-7908
10165 MCKELLAR CT. SE DECISION MADE: 04-AUG-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
RADIONICS, INC. 510(k) NO: K991237(TRADITIONAL)
ATTN: NANCY MACDONALD PHONE NO : 718-272-1233
22 TERRY AVE. SE DECISION MADE: 30-AUG-99
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARSET, MODEL A10001E
RD MEDICAL MFG., INC. 510(k) NO: K992104(ABBREVIATED)
ATTN: CARLOS A RODRIGUEZ-GARCIA PHONE NO : 787-742-3800
CALLE ESCUDERO FINAL, BO. SE DECISION MADE: 23-AUG-99
FULLADOSA 510(k) SUMMARY AVAILABLE FROM FDA
CUELBRA, PR
DEVICE: REDI-TEST PCP
REDWOOD BIOTECH INC. 510(k) NO: K991698(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 650-691-4770
2440 LEGHORN ST. SE DECISION MADE: 25-AUG-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAINAGE BAG
REMINGTON MEDICAL, INC. 510(k) NO: K990428(TRADITIONAL)
ATTN: STEVE WOODY PHONE NO : 770-888-8520
6830 MEADOWRIDGE CT. SE DECISION MADE: 12-AUG-99
ALPHARETTA, GA 30005 510(k) STATEMENT
DEVICE: ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING
RESEARCH INSTRUMENTS LTD. 510(k) NO: K991261(TRADITIONAL)
ATTN: DAVID C LANSDOWNE PHONE NO : 441 326 372753
KERNICK RD. SE DECISION MADE: 05-AUG-99
PENRYN, CORWALL, UNITED KINGDOM TR510(k) STATEMENT
DEVICE: MONARCH II MINI MASK
RESPIRONICS, INC. 510(k) NO: K992336(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DRIVE SE DECISION MADE: 13-AUG-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
RI MOS. S.R.L. 510(k) NO: K991895(TRADITIONAL)
ATTN: JAMES DELANEY PHONE NO : 978-371-0066
100 MAIN ST. SE DECISION MADE: 12-AUG-99
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA
DEVICE: RIWO DRIVE GENERATOR
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984304(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 12-AUG-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 1
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991718(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY SE DECISION MADE: 12-AUG-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K973707(TRADITIONAL)
ATTN: ALEX WESOLOWSKI PHONE NO : 908-253-7540
1080 U.S. HIGHWAY 202 SE DECISION MADE: 04-AUG-99
SOMERVILLE, NJ 08876-3711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRAT
ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K983618(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018
28025 OAKLAND OAKS CT. SE DECISION MADE: 05-AUG-99
WIXOM, MI 48393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
RON-TECH MEDICAL LTD. 510(k) NO: K992071(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 979 20673
P.O. BOX 454 SE DECISION MADE: 27-AUG-99
GINOT SHOMRON, ISRAEL 44853 510(k) STATEMENT
DEVICE: FLEXIFLO ENTERAL FEEDING TUBE
ROSS PRODUCTS, DIV. ABBOTT LABORAT510(k) NO: K992494(SPECIAL)
ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743
SE DECISION MADE: 25-AUG-99
510(k) STATEMENT
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-41
ROSSMAX INTL. LTD. 510(k) NO: K992387(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 27835584
2F. NO. 10, ALLEY 20 LANE 106 SE DECISION MADE: 03-AUG-99
SECTION 3, NAN KANG ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-42
ROSSMAX INTL. LTD. 510(k) NO: K992388(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 27835584
2F. NO. 10, ALLEY 20 LANE 106 SE DECISION MADE: 03-AUG-99
SEC 3 NON KANG RD. 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNC
RUSCH INTL. 510(k) NO: K990619(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 03-AUG-99
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS ADENO TEST
SA SCIENTIFIC, INC. 510(k) NO: K990630(TRADITIONAL)
ATTN: J. WESSLING PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 19-AUG-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SAS ROTA TEST
SA SCIENTIFIC, INC. 510(k) NO: K990842(TRADITIONAL)
ATTN: J. WESSLING PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 09-AUG-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
SAFESKIN CORP. 510(k) NO: K992062(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-794-8111
12671 HIGH BLUFF DR. SE DECISION MADE: 25-AUG-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE W
SAFESKIN CORP. 510(k) NO: K992162(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 30-AUG-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALTER LABS PEP DEVICE
SALTER LABORATORIES 510(k) NO: K991788(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 805-854-3166
100 WEST SYCAMORE RD. SE DECISION MADE: 06-AUG-99
ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
SANGSTAT MEDICAL CORP. 510(k) NO: K991594(TRADITIONAL)
ATTN: COLLEEN STEWART PHONE NO : 510-789-4540
6300 DUMBARTON CIRCLE SE DECISION MADE: 05-AUG-99
FREMONT, CA 94555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXISCOPE IQ 101
SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K992362(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 05-AUG-99
NEWTON, MA 02248 510(k) STATEMENT
DEVICE: SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
SECHRIST INDUSTRIES, INC. 510(k) NO: K992503(SPECIAL)
ATTN: GREG GODFREY PHONE NO : 714-579-8318
4225 EAST LA PALMA SE DECISION MADE: 10-AUG-99
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEDATELEC ASP ACUPUNCTURE NEEDLES
SEDATELEC 510(k) NO: K983798(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 27-AUG-99
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DN ACUPUNTURE NEEDLES
SEDATELEC 510(k) NO: K983800(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 27-AUG-99
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
SELTOM PACIFIC SDN. BHD. 510(k) NO: K991776(TRADITIONAL)
ATTN: S. SEGARAN PHONE NO : 603 735 6010
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 11-AUG-99
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM
SELTOM PACIFIC SDN. BHD. 510(k) NO: K991777(TRADITIONAL)
ATTN: S. SEGARAN PHONE NO : 603 735 6010
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 31-AUG-99
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
SELTOM PACIFIC SDN. BHD. 510(k) NO: K991778(TRADITIONAL)
ATTN: S. SEGARAN PHONE NO : 603 735 6010
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 31-AUG-99
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
SELTOM PACIFIC SDN. BHD. 510(k) NO: K991779(TRADITIONAL)
ATTN: S. SEGARAN PHONE NO : 603 735 6010
LOT 25, JALAN PJS 7/17 SE DECISION MADE: 11-AUG-99
SUNWAY INDUSTRIAL PARK 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150
DEVICE: INFANT FLOW SYSTEM
SENSORMEDICS CORP. 510(k) NO: K991972(SPECIAL)
ATTN: ALEX STENZLER PHONE NO : 800-520-4368
22705 SAVI RANCH PKWY. SE DECISION MADE: 13-AUG-99
YORBA LINDA, CA 92887-4645 510(k) STATEMENT
DEVICE: URINE DRUG SCREENING CONTROL
SERACARE TECHNOLOGY 510(k) NO: K992395(TRADITIONAL)
ATTN: RUSTY SEWELL PHONE NO : 512-445-5100
2170 WOODWARD ST. SE DECISION MADE: 26-AUG-99
AUSTIN, TX 78744-1832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K992017(TRADITIONAL)
ATTN: JOHN LAI PHONE NO : 011 862 157814213
259 YUSHU RD., SE DECISION MADE: 05-AUG-99
CANGQIAO TOWNSHIP 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA
DEVICE: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GRE
SHEN WEI (USA), INC. 510(k) NO: K992200(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 17-AUG-99
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG DILLY PLASTICS PRODUC510(k) NO: K992463(TRADITIONAL)
ATTN: XINGLAI ZHOU PHONE NO : 011 863 113830158
NO. 16 ZHI NONG RD. SE DECISION MADE: 30-AUG-99
SHIJIAZHUANG, CHINA 050051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
SIEMENS CORP. 510(k) NO: K991652(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4625
186 WOOD AVE., SOUTH SE DECISION MADE: 03-AUG-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM PROJECT 10-CT SCANNERS
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991764(TRADITIONAL)
ATTN: ALICIA JUERGENSEN PHONE NO : 908-321-3243
186 WOOD AVENUE SOUTH SE DECISION MADE: 17-AUG-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992046(TRADITIONAL)
ATTN: STEVE HESLER PHONE NO : 425-557-1629
22010 S.E. 51ST STREET SE DECISION MADE: 13-AUG-99
ISSAQUAH, WA 98027-7002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GONOSTAT GONOCOCCAL DETECTION KIT
SIERRA DIAGNOSTICS 510(k) NO: K991268(TRADITIONAL)
ATTN: DONALD R STONE PHONE NO : 202-496-7620
1900 K STREET, N.W. SE DECISION MADE: 11-AUG-99
WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K992644(SPECIAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-AUG-99
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROPLASTIC VENTILATION TUBES
SMITH & NEPHEW ENT. 510(k) NO: K992222(TRADITIONAL)
ATTN: ALICIA E FARAGE PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 26-AUG-99
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE
SMITH & NEPHEW, INC. 510(k) NO: K990666(ABBREVIATED)
ATTN: JANET JOHNSON GREEN PHONE NO : 901-396-2121
1450 BROOKS RD. SE DECISION MADE: 06-AUG-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA
SMV AMERICA 510(k) NO: K991565(TRADITIONAL)
ATTN: PHIL VERNON PHONE NO : 330-425-1340
8380 DARROW RD. SE DECISION MADE: 02-AUG-99
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNA-LOK PLUS SPINAL SYSTEM
SOFAMOR DANEK USA,INC. 510(k) NO: K991198(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 27-AUG-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
SOFTCHROME, INC. 510(k) NO: K991995(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO :
623 GLACIER DRIVE SE DECISION MADE: 27-AUG-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUND VASER SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC 510(k) NO: K991791(TRADITIONAL)
ATTN: WILLIAM W CIMINO PHONE NO : 303-926-8608
1300 PLAZA COURT NORTH # 203 SE DECISION MADE: 12-AUG-99
LAFAYETTE, CO 80026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIJECT
SPARTAN ULTRASONICS INC. 510(k) NO: K991888(TRADITIONAL)
ATTN: ALDO EAGLE PHONE NO : 636-343-8300
1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 25-AUG-99
FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS H
STRYKER ENDOSCOPY 510(k) NO: K991960(TRADITIONAL)
ATTN: N. MANI PRAKASH PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 13-AUG-99
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QS DELIVERY SYSTEM
SUB-Q, INC. 510(k) NO: K991254(TRADITIONAL)
ATTN: DAN W MILLER PHONE NO : 949-369-5751
1062-D CALLE NEGOCIO SE DECISION MADE: 23-AUG-99
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: INTER-OP METASUL ACETABULAR SYSTEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K974728(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 03-AUG-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
SURETEX PROPHYLACTICS (INDIA) LTD.510(k) NO: K992081(ABBREVIATED)
ATTN: LON D MCILVAIN PHONE NO : 334-794-4232
1500 INDUSTRIAL ROAD SE DECISION MADE: 19-AUG-99
P.O. BOX 1252 510(k) SUMMARY AVAILABLE FROM FDA
DOTHAN, AL 36302
DEVICE: SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K992457(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 27-AUG-99
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND
SWEMED LAB INTERNATIONAL AB 510(k) NO: K991273(TRADITIONAL)
ATTN: EDWARD C WILSON JR. PHONE NO : 202-637-5839
555 13TH STREET N.W. SE DECISION MADE: 18-AUG-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODIGY 4 TRANSLUCENT SHADES
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992118(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 18-AUG-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS 2
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992160(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 18-AUG-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES SPINE 510(k) NO: K991089(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 27-AUG-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: H20- TETHERED OPTION
TELEFACTOR CORP. 510(k) NO: K992291(SPECIAL)
ATTN: JAMES S BRYAN PHONE NO : 610-825-4555
1094 NEW DEHAVEN AVE. SE DECISION MADE: 06-AUG-99
WEST CONSHOHOCKEN, PA 19428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIFOCUS OPTITORQUE
TERUMO MEDICAL CORP. 510(k) NO: K992051(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
125 BLUE BALL RD. SE DECISION MADE: 10-AUG-99
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAVASCULAR ADMINISTRATION SET
THE KIPP GROUP 510(k) NO: K991932(TRADITIONAL)
ATTN: GARY WERSCHMIDT PHONE NO : 909-390-9080
930 WANAMAKER AVE. SE DECISION MADE: 20-AUG-99
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: CTD MARK I TRACTION DEVICE
THERASYS, INC. 510(k) NO: K991931(TRADITIONAL)
ATTN: EARNIE S PHILPOT PHONE NO : 937-643-3411
2295 NORTH MORAIN DR. SE DECISION MADE: 12-AUG-99
MORAINE, OH 45439 510(k) STATEMENT
DEVICE: ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION G
TILLOTSON HEALTHCARE CORP. 510(k) NO: K992428(TRADITIONAL)
ATTN: THOMAS N TILLOTSON PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 09-AUG-99
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER PROSTHESIS
TORNIER S.A. 510(k) NO: K980244(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 510-356-2640
1000 BURNETT AVENUE SE DECISION MADE: 23-AUG-99
SUITE 450 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, CA 94520
DEVICE: ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991766(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 10-AUG-99
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068
DEVICE: OPART, MODEL MRT-600
TOSHIBA AMERICA MRI, INC. 510(k) NO: K991740(TRADITIONAL)
ATTN: HSU CHANG PHONE NO : 650-872-2722
280 UTAH AVE. SE DECISION MADE: 02-AUG-99
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIA-PACK FOLATE ASSAY
TOSOH MEDICS, INC. 510(k) NO: K992365(TRADITIONAL)
ATTN: JUDITH E LOEBEL PHONE NO : 650-615-4970
347 OYSTER POINT BLVD., SE DECISION MADE: 10-AUG-99
SUITE 201 510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080
DEVICE: TOUCH TEAR IGE MICROASSAY KIT
TOUCH SCIENTIFIC, INC. 510(k) NO: K991316(TRADITIONAL)
ATTN: ALAN J TOUCH PHONE NO : 919-872-4445
3209 GRESHAM LAKE RD. SE DECISION MADE: 09-AUG-99
SUITE 112 510(k) STATEMENT
RALEIGH, NC 27615
DEVICE: MXU-125 OR TMX-125
TREX MEDICAL CORP. 510(k) NO: K992229(TRADITIONAL)
ATTN: KELVIN BURROUGHS PHONE NO : 203-731-8442
36 APPLE RIDGE RD. SE DECISION MADE: 06-AUG-99
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWO RIVERS POWER LIFT/RECLINE CHAIR
TWO RIVERS, LLC 510(k) NO: K991693(TRADITIONAL)
ATTN: CHRIS WHITAKER PHONE NO : 423-626-4990
P.O. BOX 356 SE DECISION MADE: 17-AUG-99
204 SOTH BROAD STREET 510(k) STATEMENT
NEW TAZEWELL, TN 37825
DEVICE: UM-L20/ UM-L30
UNION MEDICAL ENGENEERING CO., LTD510(k) NO: K982860(TRADITIONAL)
ATTN: ANNIE VALEZ PHONE NO : 305-663-9936
8930 S.W. 68TH COURT #H3 SE DECISION MADE: 13-AUG-99
MIAMI, FL 33156 510(k) STATEMENT
DEVICE: SKIN 2 FORTE SILICONE SHEETING
UNITED HOSPITAL TECHNOLOGIES, INC.510(k) NO: K990651(TRADITIONAL)
ATTN: SAMUEL SWETLAND PHONE NO : 954-433-7480
10320 USA TODAY WAY SE DECISION MADE: 13-AUG-99
MIRAMAR, FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROSURGE SPIRALFLO URETERAL STENT
UROSURGE, INC. 510(k) NO: K992391(TRADITIONAL)
ATTN: STEVEN J PREISS PHONE NO : 319-626-5335
2660 CROSSPARK RD. SE DECISION MADE: 18-AUG-99
CORALVILLE, IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOPOLAR ELECTRODES AND CABLES
US ENDO, INC. 510(k) NO: K992485(TRADITIONAL)
ATTN: JONEL MANCIU PHONE NO :
826 EAGLE DRIVE SE DECISION MADE: 27-AUG-99
BENSENVILLE, IL 60106 510(k) STATEMENT
DEVICE: CADPLAN HELIOS OPTION 6.0
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K984532(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3045 HANOVER STREET SE DECISION MADE: 09-AUG-99
PALO ALTO, CA 94304-1120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
VENTANA, INC. 510(k) NO: K984567(TRADITIONAL)
ATTN: JUDITH FREDERICK PHONE NO : 520-690-2731
3865 NORTH BUSINESS CENTER SE DECISION MADE: 12-AUG-99
DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
TUCSON, AZ 85705
DEVICE: VINYL POWDERED EXAM GLOVE / CAT.# 15-020
VITALCARE GROUP, INC. 510(k) NO: K992289(TRADITIONAL)
ATTN: GINGER TALLEY PHONE NO : 305-620-4007
15800 N.W. 13TH AVE. SE DECISION MADE: 04-AUG-99
MIAMI, FL 33169 510(k) STATEMENT
DEVICE: PMS 750 FINGERSWITCH
WALLACH SURGICAL DEVICES, INC. 510(k) NO: K991669(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-700-2000
235 EDISON RD. SE DECISION MADE: 12-AUG-99
ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VHS SUPRACONDYLAR PLATE SYSTEM
WALTER ABENDSCHEIN, M.D. 510(k) NO: K991806(TRADITIONAL)
ATTN: WALTER ABENDSCHEIN PHONE NO : 301-656-4317
5530 WISCONSIN AVENUE SE DECISION MADE: 06-AUG-99
SUITE 705 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
WELLS JOHNSON CO. 510(k) NO: K991437(TRADITIONAL)
ATTN: KEN RODENBURG PHONE NO : 520-298-6069
8000 SOUTH KOLB RD. SE DECISION MADE: 30-AUG-99
TUCSON, AZ 85706 510(k) STATEMENT
DEVICE: WHITESIDE BIOMECHANICS SPINAL SYSTEM
WHITESIDE BIOMECHANICS, INC. 510(k) NO: K991678(TRADITIONAL)
ATTN: DEBRA MEYER PHONE NO : 314-996-8540
12634 OLIVE BLVD. SE DECISION MADE: 12-AUG-99
ST. LOUIS, MO 63141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMU
ZEUS SCIENTIFIC, INC. 510(k) NO: K991820(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 12-AUG-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 326
TOTAL WITH SUMMARIES 211
TOTAL WITH STATEMENTS 115
Updated 10/5/1999
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