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Medical Devices
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August 2007 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-AUG-2007 THROUGH 31-AUG-2007
DEVICE: AAP APS SYSTEM
AAP IMPLANTATE AG 510(k) NO: K071852(TRADITIONAL)
ATTN: MARC SEEGERS PHONE NO : 49 307 50190
LORENZWEG 5 SE DECISION MADE: 29-AUG-07
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ACCURAY INCORPORATED 510(k) NO: K071531(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 22-AUG-07
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED SMALL BONE LOCKING SYSTEM II
ACUMED LLC 510(k) NO: K071944(SPECIAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 09-AUG-07
HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-PORT LAPAROSCOPIC ACCESS DEVICE
ADVANCED SURGICAL CONCEPTS 510(k) NO: K070158(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 23-AUG-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K070981(TRADITIONAL)
ATTN: LISA BOYLE PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 21-AUG-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020,
AGA MEDICAL CORP. 510(k) NO: K071699(SPECIAL)
ATTN: JODI L RAUS PHONE NO : 763-531-3056
5050 NATHAN LANE NORTH SE DECISION MADE: 15-AUG-07
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (W
ALARA, INC. 510(k) NO: K071682(TRADITIONAL)
ATTN: ROBERT LUNDBERG PHONE NO : 510-315-5200
47505 SEABRIDGE DRIVE SE DECISION MADE: 15-AUG-07
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL VOLUME SYRINGE
ALCON LABORATORIES 510(k) NO: K062865(TRADITIONAL)
ATTN: SEAN P GRIFFIN PHONE NO : 817-551-8015
6201 S FREEWAY SE DECISION MADE: 23-AUG-07
FT WORTH, TX 76134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K072285(TRADITIONAL)
ATTN: RICHARD J CEHOVSKY PHONE NO : 203-269-3088
10 FAIRFIELD BLVD. SE DECISION MADE: 30-AUG-07
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K071380(SPECIAL)
ATTN: PAULA MORGAN PHONE NO : 760-431-9286
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 20-AUG-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: THERMOGARD XP THERMAL REGULATION SYSTEM
ALSIUS CORP. 510(k) NO: K072234(SPECIAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON RD SE DECISION MADE: 23-AUG-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: CAMLOG LOGFIT PROSTHETIC SYSTEM
ALTATEC GMBH 510(k) NO: K071213(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 10-AUG-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: SPECTROLYSE PAI-1, MODEL 101201
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K063323(TRADITIONAL)
ATTN: DAVID TEICHER PHONE NO : 203-602-7777
500 WEST AVENUE SE DECISION MADE: 15-AUG-07
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS MINIARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K071902(TRADITIONAL)
ATTN: BRAD ONSTAD PHONE NO : 952-933-6139
10700 BREN RD., WEST SE DECISION MADE: 24-AUG-07
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE
ANGIODYNAMICS, INC. 510(k) NO: K071959(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 01-AUG-07
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K072196(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 27-AUG-07
QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
ARKRAY FACTORY USA, INC. 510(k) NO: K063771(TRADITIONAL)
ATTN: TOM SPEIKERS PHONE NO : 952-646-3168
5182 W. 76TH ST. SE DECISION MADE: 09-AUG-07
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE C
ARROW INTERNATIONAL, INC. 510(k) NO: K071538(TRADITIONAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 30-AUG-07
PO BOX 12888 510(k) SUMMARY AVAILABLE FROM FDA
READING, PA 19612-2888
DEVICE: ARTHREX UNIVERS II SHOULDER PROSTHESIS
ARTHREX, INC. 510(k) NO: K071032(SPECIAL)
ATTN: NANCY HOFT PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 20-AUG-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ARTHREX INTERFERENCE SCREW
ARTHREX, INC. 510(k) NO: K071176(TRADITIONAL)
ATTN: ANN WATERHOUSE, RAC PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 03-AUG-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI TIGHTROPE FT REPAIR KIT
ARTHREX, INC. 510(k) NO: K071978(SPECIAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 15-AUG-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS TWINLOCK KNOTLESS FIXATION DEVICE
ARTHROCARE CORP. 510(k) NO: K071374(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406
15285 ALTON PARKWAY, #200 SE DECISION MADE: 02-AUG-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SYSTEM 12000
ARTHROCARE CORP. 510(k) NO: K071709(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 07-AUG-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K071963(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 07-AUG-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE SPINEWAND
ARTHROCARE CORP. 510(k) NO: K072089(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 17-AUG-07
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICE
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K070034(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 17-AUG-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVI
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K070036(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5300
10232 SOUTH 51ST ST. SE DECISION MADE: 17-AUG-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TATTOOSTAR Y
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K071451(SPECIAL)
ATTN: ANTJE KATZER PHONE NO : 49 364 17700309
1A; IM SEMMICHT SE DECISION MADE: 01-AUG-07
JENA, GERMANY 07751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
ATCOR MEDICAL PTY. LTD 510(k) NO: K070795(TRADITIONAL)
ATTN: EVAN P PHELPS PHONE NO : 202-789-1212
1400 16TH STREET, NW SE DECISION MADE: 31-AUG-07
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: PTFE FLIXENE GRADUATED WALL GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K071923(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 14-AUG-07
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGE
B. BRAUN MEDICAL, INC. 510(k) NO: K071459(TRADITIONAL)
ATTN: CHRISTINE FORD PHONE NO : 610-596-2367
901 MARCON BLVD. SE DECISION MADE: 16-AUG-07
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20)
B. BRAUN MEDIZINTECHNOLOGIE GMBH 510(k) NO: K071518(TRADITIONAL)
ATTN: SUSAN OLINGER PHONE NO : 610-596-2517
901 MARCON BOULEVARD SE DECISION MADE: 17-AUG-07
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
BARTON MEDICAL CORP. 510(k) NO: K071793(TRADITIONAL)
ATTN: LAWRENCE W SWOL PHONE NO : 512-476-7199
5725 HWY 290 WEST, #103 SE DECISION MADE: 03-AUG-07
AUSTIN, TX 78735-8701 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES
BAUSCH & LOMB, INC. 510(k) NO: K071043(ABBREVIATED)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 02-AUG-07
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
BAUSCH & LOMB, INC. 510(k) NO: K071266(TRADITIONAL)
ATTN: MICHAEL A SANTALUCIA PHONE NO : 585-338-8731
1400 NORTH GOODMAN ST. SE DECISION MADE: 15-AUG-07
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWABBABLE CAP, MODEL 60205
BAXA CORP. 510(k) NO: K070163(TRADITIONAL)
ATTN: KIMBERLY ZIZIK PHONE NO : 303-617-2242
14445 GRASSLANDS DR. SE DECISION MADE: 03-AUG-07
ENGLEWOOD, CO 80112-7062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (
BECTON, DICKINSON & CO. 510(k) NO: K071623(TRADITIONAL)
ATTN: VICKI K WHITLEY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 20-AUG-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGERTIP PULSE OXIMETER MD300C
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K070371(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D ZHONGXIN ZHONGSHAN SE DECISION MADE: 13-AUG-07
MANSION, NO. 19 LANE, 999 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, SHANGHAI, CHINA 20020
DEVICE: BENZ-G 4X HIOXIFILCON D
BENZ RESEARCH AND DEVELOPMENT CORP510(k) NO: K062854(TRADITIONAL)
ATTN: ARTHUR J WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 06-AUG-07
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTLOCK SCREW, ST SCREW
BIOCOMPOSITES LTD. 510(k) NO: K071952(SPECIAL)
ATTN: SIMON FITZER PHONE NO : 44 178 2338580
KEELE SCIENCE PARK SE DECISION MADE: 14-AUG-07
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOMINATOR
BIOCOMPOSITES LTD. 510(k) NO: K072127(SPECIAL)
ATTN: SIMON FITZER PHONE NO : 441 782 338580
KEELE SCIENCE PARK SE DECISION MADE: 31-AUG-07
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 150W CERALAS D 980NM DIODE LASER
BIOLITEC, INC. 510(k) NO: K072106(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 30-AUG-07
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKBRIDGE TM CYLINDER AND CAP
BIOMET 3I, INC. 510(k) NO: K071551(TRADITIONAL)
ATTN: DIANA TAYLOR PHONE NO : 561-776-6857
4555 RIVERSIDE DR. SE DECISION MADE: 30-AUG-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS BE RODS
BIOMET SPINE 510(k) NO: K071377(TRADITIONAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PARKWAY SE DECISION MADE: 06-AUG-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK KNOTLESS ANCHORS
BIOMET SPORTS MEDICINE, INC. 510(k) NO: K070389(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 09-AUG-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581
DEVICE: ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RF
BIORETEC LTD 510(k) NO: K071863(SPECIAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 207 789500
HERMIAKATU 22 MODULIGHT BLDG SE DECISION MADE: 31-AUG-07
TAMERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALASE THERMAL THERAPY SYSTEM
BIOTEX, INC. 510(k) NO: K071328(TRADITIONAL)
ATTN: MATTHEW FOX PHONE NO : 713-741-0111
8058 EL RIO ST. SE DECISION MADE: 31-AUG-07
HOUSTON, TX 77054-4185 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
BOSTONSCIENTIFIC 510(k) NO: K070002(ABBREVIATED)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-683-4003
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 17-AUG-07
MARLBOROUGH, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
C.R. BARD, INC. 510(k) NO: K070201(TRADITIONAL)
ATTN: MICHELLE GUDITH PHONE NO : 770-784-6722
8195 INDUSTRIAL BLVD. SE DECISION MADE: 01-AUG-07
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
CANDELA CORP. 510(k) NO: K071469(TRADITIONAL)
ATTN: JEFFREY ROBERTS PHONE NO : 508-358-7400
530 BOSTON POST ROAD SE DECISION MADE: 15-AUG-07
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
CANTERBURY SCIENTIFIC LTD. 510(k) NO: K071648(TRADITIONAL)
ATTN: MAURICE OWEN PHONE NO : 643 343 3345
14 POPE STREET SE DECISION MADE: 22-AUG-07
RICCARTON 510(k) SUMMARY AVAILABLE FROM FDA
CHRISTCHURCH, NEW ZEALAND 8001
DEVICE: AIRLIFE NEBULIZER CAP
CARDINAL HEALTH 510(k) NO: K072119(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 848-578-6610
1430 WAUKEGAN RD. SE DECISION MADE: 10-AUG-07
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K071350(TRADITIONAL)
ATTN: MICHAEL J KALLOK PHONE NO : 651-259-1610
651 CAMPUS DR. SE DECISION MADE: 22-AUG-07
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K071427(SPECIAL)
ATTN: CINDY SETUM PHONE NO : 651-259-1650
651 CAMPUS DR. SE DECISION MADE: 30-AUG-07
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHISON, MODEL 8300
CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K072210(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
STE 8 ZHONGSHAN MANSION, LANE SE DECISION MADE: 24-AUG-07
999, ZHONGSHAN NO.02 RD (S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030 THIRD PARTY REVIEW
DEVICE: OPACIDEN SOLUTION
CIDEN TECHNOLOGIES LLC 510(k) NO: K070627(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713-664-6775
540 COLLEGE ST. SE DECISION MADE: 02-AUG-07
BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICATH, STERILESURE
COLORADO CATHETER COMPANY, INC. 510(k) NO: K071496(TRADITIONAL)
ATTN: DOUG WILSON PHONE NO : 719-495-7136
15975 WINDING TRAIL ROAD SE DECISION MADE: 15-AUG-07
COLORADO SPRINGS, CO 80908 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFIED MERCI RETRIEVER, MODEL 90060
CONCENTRIC MEDICAL, INC. 510(k) NO: K071172(TRADITIONAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 22-AUG-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED LINVATEC 300W XENON LIGHT SOURCE
CONMED LINVATEC 510(k) NO: K070376(TRADITIONAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234
11311 CONCEPT BOULEVARD SE DECISION MADE: 20-AUG-07
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED LINVATEC XO BUTTON
CONMED LINVATEC 510(k) NO: K070780(TRADITIONAL)
ATTN: JOY LOVETT PHONE NO : 727-399-5137
11311 CONCEPT BOULEVARD SE DECISION MADE: 21-AUG-07
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 300D HOME OXYGEN LIQUEFIER
COPD PARTNERS, INC. 510(k) NO: K071461(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 21-AUG-07
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: REVERTO 55 AND 37 SHAPE MEMORY STAPLES
CORE ESSENCE ORTHOPAEDICS, LLC 510(k) NO: K071477(TRADITIONAL)
ATTN: SHAWN T HUXEL PHONE NO : 215-310-9534
301 OXFORD VALLEY RD. SE DECISION MADE: 15-AUG-07
SUITE 905B 510(k) SUMMARY AVAILABLE FROM FDA
YARDLEY, PA 19067
DEVICE: RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
CORE ESSENCE ORTHOPAEDICS, LLC 510(k) NO: K071520(TRADITIONAL)
ATTN: SHAWN T HUXEL PHONE NO : 215-310-9534
301 OXFORD VALLEY RD. SE DECISION MADE: 10-AUG-07
SUITE 905B 510(k) SUMMARY AVAILABLE FROM FDA
YARDLEY, PA 19067
DEVICE: 4DDOME
COUSIN BIOTECH 510(k) NO: K070918(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. #102 SE DECISION MADE: 22-AUG-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPORT ELECTRODE
CYBERKINETICS NEUROTECHNOLOGY SYST510(k) NO: K070272(TRADITIONAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 03-AUG-07
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX RF KIT
DADE BEHRING, INC. 510(k) NO: K071247(TRADITIONAL)
ATTN: HELEN LEE PHONE NO : 302-631-8706
GLASGOW SITE SE DECISION MADE: 08-AUG-07
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTI
DADE BEHRING, INC. 510(k) NO: K071316(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 20-AUG-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTI
DADE BEHRING, INC. 510(k) NO: K071317(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 20-AUG-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
DADE BEHRING, INC. 510(k) NO: K071767(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 04-AUG-07
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: ETOH FLEX REAGENT CARTRIDGE (DF22)
DADE BEHRING, INC. 510(k) NO: K071811(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 24-AUG-07
P.O. BOX 6101; MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
DADE BEHRING, INC. 510(k) NO: K071834(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 17-AUG-07
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DEN TEK COMFORT FIT NIGHTGUARD
DEN TEK ORAL CARE, INC. 510(k) NO: K072147(SPECIAL)
ATTN: HOWARD HOLSTEIN, ESQ. PHONE NO : 202-637-5813
555 THIRTEENTH STREET, NW SE DECISION MADE: 30-AUG-07
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGRAF/D-300
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072052(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
1311 SMILE WAY SE DECISION MADE: 08-AUG-07
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGRAF/D-700
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072056(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
1311 SMILE WAY SE DECISION MADE: 06-AUG-07
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGRAF/LD-300
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K072057(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 06-AUG-07
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: MODIFICATION TO: OSTEOGRAF/N-700
DENTSPLY INTERNTIONAL 510(k) NO: K072058(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 03-AUG-07
SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: HEALIX ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K071481(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988
325 PARAMOUNT DR. SE DECISION MADE: 09-AUG-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GCK TIBIAL COMPONENTS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K070267(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923
700 ORTHOPAEDIC DR. SE DECISION MADE: 17-AUG-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071417(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 02-AUG-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: VIPER SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K071860(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 01-AUG-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K070206(TRADITIONAL)
ATTN: GAIL GOODRUM PHONE NO : 740-593-1784
350 WEST STATE ST. SE DECISION MADE: 30-AUG-07
ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISSION OLYMPUS AU ISE CALIBRATORS
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K071039(TRADITIONAL)
ATTN: KATHRYN THORSEN PHONE NO : 508-429-0450
333 FISKE ST. SE DECISION MADE: 08-AUG-07
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
DIGITAL HEALTHCARE, LTD. 510(k) NO: K071299(TRADITIONAL)
ATTN: GERRY SKEWS PHONE NO : 919-554-9650
343 SOUTH WHITE ST. SE DECISION MADE: 31-AUG-07
WAKE FOREST, NC 27587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
DOLOMITE BIOTECH SDN BHD 510(k) NO: K070117(TRADITIONAL)
ATTN: TIMOTHY LIEW PHONE NO : 510-686-2481
417 WHITNEY STREET SE DECISION MADE: 06-AUG-07
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE ECSCOPE
DYANSYS CORP 510(k) NO: K072353(TRADITIONAL)
ATTN: SRINI NAGESHWAR PHONE NO : 408-354-8447
577 AIRPORT BLVD., SUITE 610 SE DECISION MADE: 30-AUG-07
BURLINGAME, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THE PORTABLE ANSISCOPE
DYANSYS, INC. 510(k) NO: K071168(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925-254-5228
8 SNOWBERRY COURT SE DECISION MADE: 31-AUG-07
ORINDA, CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH
E SURGICAL, LLC 510(k) NO: K071080(TRADITIONAL)
ATTN: HANS J RICHTER PHONE NO : 925-280-8388
1910 N. CALIFORNIA BLVD. SE DECISION MADE: 31-AUG-07
SUITE 1040 510(k) SUMMARY AVAILABLE FROM FDA
WALNUT CREEK, CA 94596
DEVICE: DEEP BLUE
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K071722(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 10-AUG-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EKOS MICRO-INFUSION SYSTEM
EKOS CORP. 510(k) NO: K063620(TRADITIONAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132
11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 06-AUG-07
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOWAVE INFUSION SYSTEM
EKOS CORP. 510(k) NO: K071933(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132
11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 10-AUG-07
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
ELITE SURGICAL SUPPLIES (PTY) LTD.510(k) NO: K063453(TRADITIONAL)
ATTN: CHARISE DE BARRIOS PHONE NO : 404-408-2396
503 COMMERCE PARK DRIVE SE DECISION MADE: 30-AUG-07
SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30060
DEVICE: VENDYS MODEL 5000 B/BC
ENDOTHELIX, INC. 510(k) NO: K060980(TRADITIONAL)
ATTN: DOUGLAS BLAKELY PHONE NO : 713-529-2599
2472 BOLSOVER SE DECISION MADE: 16-AUG-07
SUITE 439C 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77005
DEVICE: MYLAB30, MODEL 7300
ESAOTE S.P.A. 510(k) NO: K071996(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500
11460 N. MERIDIAN ST. SE DECISION MADE: 03-AUG-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032 THIRD PARTY REVIEW
DEVICE: INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND
ETHICON ENDO-SURGERY, LLC 510(k) NO: K070151(TRADITIONAL)
ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123
4545 CREEK ROAD SE DECISION MADE: 15-AUG-07
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-
EVERLIFE MEDICAL EQUIPMENT CO., LT510(k) NO: K071320(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 229 189838
NO. 58, FU-CHIUN STREET SE DECISION MADE: 17-AUG-07
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
EXACTECH, INC. 510(k) NO: K071738(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 15-AUG-07
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DASH
EZSURGICAL 510(k) NO: K071775(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 07-AUG-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: INSIGHT DISCOVERY
FASSTECH 510(k) NO: K063447(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 978-663-2800
76 TREBLE COVE RD. SE DECISION MADE: 16-AUG-07
BUILDING #2 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862 THIRD PARTY REVIEW
DEVICE: FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
FEGO PRECISION INDUSTRIAL CO; LTD 510(k) NO: K070209(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DRIVE SE DECISION MADE: 08-AUG-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
FERTI PRO N.V. 510(k) NO: K070135(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVENUE SAUSALITO SE DECISION MADE: 16-AUG-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL MATRIX BAND
FLY CAST TECHNOLOGIES, INC. 510(k) NO: K071858(TRADITIONAL)
ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 31-AUG-07
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT TACROLIMUS: MODEL 1L77
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K070820(TRADITIONAL)
ATTN: DIANA DICKSON PHONE NO : 610-240-3917
201 GREAT VALLEY PKWY. SE DECISION MADE: 01-AUG-07
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MOD
GAMBRO BCT, INC. 510(k) NO: K071079(TRADITIONAL)
ATTN: PATTI L ARNDT PHONE NO : 303-231-4832
10810 WEST COLLINS AVE. SE DECISION MADE: 02-AUG-07
LAKEWOOD, CO 80215-4415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC-ZIRCONIA
GC AMERICA, INC. 510(k) NO: K071674(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 09-AUG-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: LULLABY
GE HEALTHCARE CLINICAL SYSTEMS 510(k) NO: K071828(TRADITIONAL)
ATTN: THALIA BRINE PHONE NO : 410-888-5257
8880 GORMAN ROAD SE DECISION MADE: 06-AUG-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
GENERAL ELECTRIC CO. 510(k) NO: K071985(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 17-AUG-07
WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GE LOGIQ A3
GENERAL ELECTRIC CO. 510(k) NO: K072075(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
9900 INNOVATION DRIVE SE DECISION MADE: 29-AUG-07
MAIL CODE: RP-2138 510(k) SUMMARY AVAILABLE FROM FDA
WAUWATOSA, WI 53226
DEVICE: GSO GS1 SPACER
GOLD STANDARD ORTHOPEDICS LLC 510(k) NO: K071274(TRADITIONAL)
ATTN: DAVID BAUGHMAN PHONE NO : 502-581-8770
1226 ROWAN ST. SE DECISION MADE: 24-AUG-07
LOUISVILLE, KY 40203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCTOR'S LIGHT LED DENTAL CURING LIGHT
GOOD DOCTORS CO., LTD. 510(k) NO: K071908(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 23-AUG-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: OPACIDEN OPA REAGENT STRIPS
HACH COMPANY 510(k) NO: K070419(TRADITIONAL)
ATTN: DAVID A MORRIS PHONE NO : 219-262-2060
23575 COUNTY ROAD 106 SE DECISION MADE: 31-AUG-07
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMI
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K070630(TRADITIONAL)
ATTN: DENICE WROE PHONE NO : 877-847-4542
PO BOX 160435 BLDG E-13 DOOR21 SE DECISION MADE: 31-AUG-07
FREEPORT CENTER BLDG 510(k) STATEMENT
CLEARFIELD, UT 84016
DEVICE: HEARTWAY POWER MOBILITY SCOOTER, PF6
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K072104(TRADITIONAL)
ATTN: HSIANG-PIN HUANG PHONE NO : 886 423 580357
ROAD 25, NO. 6 SE DECISION MADE: 17-AUG-07
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 408
DEVICE: HEMCON CHITOFLEX-SURGICAL DRESSING
HEMCON, INC. 510(k) NO: K071519(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459
10575 SW CASCADE AVENUE SE DECISION MADE: 06-AUG-07
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
PORTLAND, OR 97223-4363
DEVICE: MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
HIGH MOMENTUM SDN BHD 510(k) NO: K071207(TRADITIONAL)
ATTN: HUE K FAH PHONE NO : 603 339 23375
BANDAR BUKIT TINGGI KLANG SE DECISION MADE: 07-AUG-07
PELABUHAN KLANG 510(k) STATEMENT
SELANGOR DAURL EHSAN, MALAYSIA 42100
DEVICE: ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K071806(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 28-AUG-07
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SCORPIO NRG KNEE SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K071991(SPECIAL)
ATTN: PATRICIA SETTI-LAPERCH PHONE NO : 201-831-5938
325 CORPORATE DR. SE DECISION MADE: 15-AUG-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XEBRA DICOM IMAGE BROWSER
HX TECHNOLOGIES, INC. 510(k) NO: K071894(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 16-AUG-07
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
IMPLANTECH ASSOCIATES INC. 510(k) NO: K071470(TRADITIONAL)
ATTN: STEPHEN MEADE PHONE NO : 805-339-9415
6025 NICOLLE ST., SUITE B SE DECISION MADE: 31-AUG-07
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: INION HEXALON BIODEGRADABLE ACL/PCL SCREW
INION OY 510(k) NO: K071464(TRADITIONAL)
ATTN: KATI MARTTINEN PHONE NO : 358 108 306600
LAAKARINKATU 2 SE DECISION MADE: 03-AUG-07
TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVASA STAT*SEAL TOPICAL HEMOSTAT
INNOVASA, INC. 510(k) NO: K071225(TRADITIONAL)
ATTN: ROBERTA HINES PHONE NO : 425-481-8380
16625 REDMOND WAY SE DECISION MADE: 31-AUG-07
PMB M-316 510(k) STATEMENT
REDMOND, WA 98052
DEVICE: SERENITY PRO PSF SYSTEM
INOLASE 2002, LTD. 510(k) NO: K071943(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 10-AUG-07
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN P.004 RC GOLD ABUTMENT
INSTITUT STRAUMANN AG 510(k) NO: K070549(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 31-AUG-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PRO
INSTITUT STRAUMANN AG 510(k) NO: K072071(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513
60 MINUTEMAN ROAD SE DECISION MADE: 15-AUG-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRUMED RETRACTORS
INSTRUMED INTERNATIONAL, INC. 510(k) NO: K071771(ABBREVIATED)
ATTN: MICHAEL MASSONG PHONE NO : 847-908-0292
626 COOPER COURT SE DECISION MADE: 02-AUG-07
SCHAUMBURG, IL 60173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL RECOMBIPLASTIN 2G
INSTRUMENTATION LABORATORY CO. 510(k) NO: K070005(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 15-AUG-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAGEN XS DURAL REGENERATION MATRIX
INTEGRA LIFESCIENCES CORP. 510(k) NO: K072207(SPECIAL)
ATTN: PETER ALLAN PHONE NO : 609-936-2237
311C ENTERPRISE DRIVE SE DECISION MADE: 23-AUG-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K071505(TRADITIONAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495
311 ENTERPRISE DR. SE DECISION MADE: 06-AUG-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
INTEGRA RADIONICS, INC. 510(k) NO: K071669(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227
22 TERRY AVENUE SE DECISION MADE: 17-AUG-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFS BONE FIXATION DEVICES
INTERNAL FIXATION SYSTEMS, INC. 510(k) NO: K071035(TRADITIONAL)
ATTN: STEVE HERNANDEZ PHONE NO : 305-216-4766
10100 N.W. 116TH WAY, STE. 18 SE DECISION MADE: 13-AUG-07
MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRINSIC THERAPEUTICS FIXATION STAPLE
INTRINSIC THERAPEUTICS INCORPORATE510(k) NO: K071637(TRADITIONAL)
ATTN: KRISHNA UPPUGONDURI PHONE NO : 781-932-0222
30 COMMERCE WAY SE DECISION MADE: 03-AUG-07
WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC,
ISOTIS NV 510(k) NO: K061880(TRADITIONAL)
ATTN: ELAINE SCHUTTE PHONE NO : 30 30 2295253
PROF. BRONKHORSTLAAN 10-D SE DECISION MADE: 15-AUG-07
3723 MB 510(k) SUMMARY AVAILABLE FROM FDA
BILTHOVEN, NETHERLANDS 3723 MB
DEVICE: IPS INLINE POM SYSTEM
IVOCLAR VIVADENT, INC. 510(k) NO: K071848(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 30-AUG-07
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODIAGNOSTIX (R) 5.72
IVS SOLUTIONS AG 510(k) NO: K071636(ABBREVIATED)
ATTN: FRANK STOCKMANN PHONE NO : 493 715 347380
ANNABERGET STRASSE 240 SE DECISION MADE: 09-AUG-07
CHEMNITZ, SAXONY, GERMANY 09125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROOT ZX II
J. MORITA USA, INC. 510(k) NO: K071190(TRADITIONAL)
ATTN: ROBERT A SILVERMAN PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 17-AUG-07
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS
JAWON MEDICAL CO., LTD. 510(k) NO: K071884(SPECIAL)
ATTN: HL JUNG PHONE NO : 2 626 49001
ROOM 624, LIFE OFFICETEL, 61-3 SE DECISION MADE: 09-AUG-07
YOIDO-DONG, YOUNGDEUNGPO-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, KOREA, REPUBLIC OF KOREA 150-731
DEVICE: DELTA SPINAL FUSION SYSTEM
JEMO SPINE, LLC 510(k) NO: K071857(TRADITIONAL)
ATTN: PATRICK MOORE PHONE NO : 801-266-4811
6170 SOUTH 380 WEST, SUITE 200 SE DECISION MADE: 08-AUG-07
MURRAY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
JOHNSON & JOHNSON CONSUMER PRODUCT510(k) NO: K071710(TRADITIONAL)
ATTN: DAGMAR OETTE PHONE NO : 973-385-4619
201 TABOR ROAD SE DECISION MADE: 14-AUG-07
MORRIS PLAINS, NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STORZ SLX-F2 STORM TOUCH
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K070579(SPECIAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 30-AUG-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K071530(TRADITIONAL)
ATTN: SUSIE CHEN PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 24-AUG-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMCAT THROMBECTOMY CATHETER SYSTEM
KENSEY NASH CORP. 510(k) NO: K072195(SPECIAL)
ATTN: CINDY R VARUGHESE PHONE NO : 484-713-2100
735 PENNSYLVANIA DRIVE SE DECISION MADE: 23-AUG-07
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFO
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K070360(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-6600
180 ENTERPRISE DR. SE DECISION MADE: 07-AUG-07
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K070826(TRADITIONAL)
ATTN: LIU YI PHONE NO : 86 22 60528012
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 15-AUG-07
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K070828(TRADITIONAL)
ATTN: LIU YI PHONE NO : 862 260 528012
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 15-AUG-07
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: FORU KV10HB
KWANG YANG MOTOR CO., LTD. 510(k) NO: K072027(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396
14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 20-AUG-07
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
LANGFANG HUILONG PLASTIC PRODUCT C510(k) NO: K071685(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
RM1606. BLDG.1 JIANXIANG YUAN SE DECISION MADE: 06-AUG-07
NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
LANGFANG HUILONG PLASTIC PRODUCT C510(k) NO: K071686(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
RM1606. BLDG.1 JIANXIANG YUAN SE DECISION MADE: 22-AUG-07
NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: LANX DEFORMITY SYSTEM
LANX, LLC 510(k) NO: K071633(SPECIAL)
ATTN: JANICE HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET, 28TH FLOOR SE DECISION MADE: 15-AUG-07
PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
LDR SPINE USA 510(k) NO: K070341(TRADITIONAL)
ATTN: JAMES BURROWS PHONE NO : 512-344-3307
4030 WEST BRAKER LANE SE DECISION MADE: 08-AUG-07
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: LDR SPINE ROI-T SYSTEM
LDR SPINE USA 510(k) NO: K072132(SPECIAL)
ATTN: JAMES BURROWS PHONE NO : 512-344-3307
4030 WEST BRAKER LANE SE DECISION MADE: 30-AUG-07
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
LEMAITRE VASCULAR, INC. 510(k) NO: K071367(SPECIAL)
ATTN: MINNIE MILDWOFF PHONE NO : 781-221-2266
63 2ND AVENUE SE DECISION MADE: 29-AUG-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
LIFE-SHIELD PRODUCTS, INC 510(k) NO: K072037(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 08-AUG-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESYNC ADAPTER, MODEL LS-302
LIFESYNC CORPORATION 510(k) NO: K071751(ABBREVIATED)
ATTN: DIANE SUDDUTH PHONE NO : 954-344-5891
8282 SHADOWWOOD DRIVE SE DECISION MADE: 27-AUG-07
CORAL SPRINGS, FL 33071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LLOYD LINDEN, MODEL E04
LLOYD LINDEN, INC. 510(k) NO: K071761(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
ZHUANGJING ROAD SE DECISION MADE: 03-AUG-07
BANQIAO, TAIPEI COUNTY, CHINA (TAI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ BIOTECH APTIVA, VERSION 2.13
LORENZ BIOTECH S.P.A. 510(k) NO: K061828(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 24-AUG-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTRACT CATHETER SYSTEM
LUMEN BIOMEDICAL, INC. 510(k) NO: K071529(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 763-746-9550
14505 21ST AVE. NORTH SE DECISION MADE: 10-AUG-07
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: TESLA NIBP
MAMMENDORFER INSTITUT FUR PHYSIK U510(k) NO: K062974(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 W. 7TH AVE. SE DECISION MADE: 13-AUG-07
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
MAQUET CARDIOPULMONARY AG 510(k) NO: K072172(SPECIAL)
ATTN: KATRIN SCHWENGLENKS PHONE NO : 011 49 74789210
HECHINGER STRASSE 38 SE DECISION MADE: 31-AUG-07
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELVIMESH / HERMESH 7
MARKETING SOLUTIONS INC. 510(k) NO: K070625(TRADITIONAL)
ATTN: LORENA TRABUCCO PHONE NO : 516-938-3042
8 ORANGE DR. SE DECISION MADE: 01-AUG-07
JERICHO, NY 11753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEASSIST SYSTEM
MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K063607(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 23-AUG-07
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYRA CLINICAL CHEMISTRY ANALYZER
MEDICA CORP. 510(k) NO: K070057(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
5 OAK PARK DRIVE SE DECISION MADE: 30-AUG-07
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: IGUIDE SYSTEM
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K072079(TRADITIONAL)
ATTN: MICHAEL WOLFF PHONE NO : 49 823 2969235
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 14-AUG-07
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SOLAR GI
MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K071094(TRADITIONAL)
ATTN: KARIN OGINK-SOMHORST PHONE NO : 31 53 4803739
COLOSSEUM 25 SE DECISION MADE: 13-AUG-07
ENSCHEDE, NETHERLANDS 7521 PV 510(k) STATEMENT
DEVICE: C-JAWS CERVICAL COMPRESSIVE MINI FRAME
MEDICREA TECHNOLOGIES 510(k) NO: K072040(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 03-AUG-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES
MEDIGROUP, INC. 510(k) NO: K071167(TRADITIONAL)
ATTN: JOHN A NAVIS PHONE NO : 630-554-5533
14 A STONEHILL RD. SE DECISION MADE: 31-AUG-07
OSWEGO, IL 60543-9400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
MEDITECH KFT. 510(k) NO: K071960(SPECIAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 47880
INDUSTRIAL PARK 13 M.P. MISGAV SE DECISION MADE: 03-AUG-07
MIZPE AVIV, ISRAEL 20187 510(k) STATEMENT
DEVICE: MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL
MEDIVANCE, INC. 510(k) NO: K071341(SPECIAL)
ATTN: LYNNE ARONSON PHONE NO : 303-327-5151
1172 CENTURY DR., SUITE 240 SE DECISION MADE: 03-AUG-07
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR C
MEDTRONIC NEUROSURGERY 510(k) NO: K063836(TRADITIONAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 16-AUG-07
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 XVBR SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K071033(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-AUG-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISAGE PACS/CS, RELEASE VERSION 5.0
MERCURY COMPUTER SYSTEMS, INC 510(k) NO: K072205(SPECIAL)
ATTN: MARTIN GABLER PHONE NO : 49 404 7103618
BEIM STROHHAUSE 27 SE DECISION MADE: 29-AUG-07
HAMBURG, GERMANY 20097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
MERZ DENTAL GMBH 510(k) NO: K071548(TRADITIONAL)
ATTN: RICHARD G HUNTER PHONE NO : 770-851-1827
5616 MARIOLA PL NE SE DECISION MADE: 21-AUG-07
ALBUQUERQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICATOR PLUS 940, MODEL ME940
METTLER ELECTRONICS CORP. 510(k) NO: K071137(ABBREVIATED)
ATTN: ROB FLEMING PHONE NO : 800-854-9305
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 01-AUG-07
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
MICROSURGEON, INC. 510(k) NO: K070023(TRADITIONAL)
ATTN: DUDLEY HARRIS PHONE NO : 970-252-8107
20662 EAST TULIP CIRCLE SE DECISION MADE: 15-AUG-07
MONTROSE, CO 81401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBOUND HRD
MINNESOTA MEDICAL DEVELOPMENT, INC510(k) NO: K063671(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 16-AUG-07
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF JUNIOR HEMOFILTER
MINNTECH CORP. 510(k) NO: K071298(TRADITIONAL)
ATTN: LYNN LUEDERS PHONE NO : 763-553-2475
14605 28TH AVE. NORTH SE DECISION MADE: 08-AUG-07
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MHI-TM2000 LINEAR ACCELERATOR SYSTEM
MITSUBISHI HEAVY INDUSTRIES, LTD. 510(k) NO: K072047(TRADITIONAL)
ATTN: TAKASHI YAMAKAWA PHONE NO : 81 822 912146
4-6-22 KAN-ON-SHIN-MACHI SE DECISION MADE: 29-AUG-07
NISHI-KU 510(k) SUMMARY AVAILABLE FROM FDA
HIROSHIMA-SHI, JAPAN 733-8553
DEVICE: AXIS-V MONOCHROME 5 MP DISPLAY
NATIONAL DISPLAY SYSTEMS 510(k) NO: K063066(TRADITIONAL)
ATTN: RON HANSON PHONE NO : 408-776-0085
16245 VINEYARD BLVD. SE DECISION MADE: 03-AUG-07
MORGAN HILL, CA 95037 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEOGUIDE ENDOSCOPY SYSTEM
NEOGUIDE SYSTEMS, INC. 510(k) NO: K070622(TRADITIONAL)
ATTN: JORGE L PORRAS PHONE NO : 408-399-9999
104 COOPER COURT SE DECISION MADE: 14-AUG-07
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K071308(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649
NO. 16, SHIJI ROAD SE DECISION MADE: 16-AUG-07
HUNNAN INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110179
DEVICE: QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIO
NIHON KOHDEN AMERICA, INC. 510(k) NO: K072060(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 17-AUG-07
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
NIHON KOHDEN AMERICA, INC. 510(k) NO: K072217(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 30-AUG-07
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELACTIVE INTERNAL CONNECTION IMPLANT
NOBEL BIOCARE AB 510(k) NO: K071370(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 03-AUG-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K063190(TRADITIONAL)
ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842
300 PALM ST. SE DECISION MADE: 21-AUG-07
SCRANTON, PA 18505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL PULSE OXIMETER, MODEL 7500FO
NONIN MEDICAL, INC. 510(k) NO: K071415(TRADITIONAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 08-AUG-07
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE HELIX ACP SYSTEM
NUVASIVE, INC. 510(k) NO: K071329(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 08-AUG-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE OCT SYSTEM
NUVASIVE, INC. 510(k) NO: K071435(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 06-AUG-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
NXSTAGE MEDICAL, INC. 510(k) NO: K071263(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 24-AUG-07
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSIGN CENTRAL STATION
OBS MEDICAL 510(k) NO: K071606(TRADITIONAL)
ATTN: WAYNE NETHERCUTT PHONE NO : 317-581-9236
12900 N. MERIDIAN ST. STE. 120 SE DECISION MADE: 31-AUG-07
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNI
OHMEDA MEDICAL 510(k) NO: K072157(SPECIAL)
ATTN: AGATA SMIEJA PHONE NO : 410-888-5218
8880 GORMAN RD. SE DECISION MADE: 27-AUG-07
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL#
OLYMPUS LIFE & MATERIAL SCIENCE EU510(k) NO: K070708(TRADITIONAL)
ATTN: STEPHANIE G SCHWARTZ PHONE NO : 011 353 656831100
LISMEEHAN, O'CALLAGHANS MILLS SE DECISION MADE: 21-AUG-07
CO. CLARE, IRELAND 510(k) STATEMENT
DEVICE: APEX HCLA ACETABULAR CUP LINERS
OMNILIFE SCIENCE 510(k) NO: K062489(TRADITIONAL)
ATTN: EDWARD CHEAL PHONE NO : 508-824-2444
175 PARAMOUNT DR SE DECISION MADE: 15-AUG-07
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
RAYNHAM, MA 02767
DEVICE: FORTAGEN ORAL MEMBRANE
ORGANOGENESIS, INC. 510(k) NO: K071555(TRADITIONAL)
ATTN: PATRICK R BILBO PHONE NO : 781-401-1155
150 DAN RD. SE DECISION MADE: 30-AUG-07
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM HIP TOOL LOCKING PLATE
ORTHOPEDIC SCIENCES, INC 510(k) NO: K072175(SPECIAL)
ATTN: JAMES K BRANNON PHONE NO : 562-799-5550
3020 OLD RANCH PARKWAY SE DECISION MADE: 21-AUG-07
SUITE 325 510(k) SUMMARY AVAILABLE FROM FDA
SEAL BEACH, CA 90740
DEVICE: NANO-BOND II ADHESIVE SYSTEM
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K071500(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 10-AUG-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
PENUMBRA, INC. 510(k) NO: K070970(TRADITIONAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 510-618-3223
2401 MERCED ST., SUITE 200 SE DECISION MADE: 17-AUG-07
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIRING - ANNULOPLASTY RING WITH SIZERS
PETERS SURGICAL 510(k) NO: K071281(TRADITIONAL)
ATTN: ROBERT RENAULT PHONE NO : 330 148 106262
Z.I. LES VIGNES SE DECISION MADE: 03-AUG-07
42 RUE BENOIT FRACHON 510(k) SUMMARY AVAILABLE FROM FDA
BOBIGNY, FRANCE 93013
DEVICE: MODIFICATION TO EZ HUBER SAFETY INFUSION SET
PFM MEDICAL, INC 510(k) NO: K071846(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 949-463-6146
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 30-AUG-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056 THIRD PARTY REVIEW
DEVICE: IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
PHADIA AB 510(k) NO: K071913(TRADITIONAL)
ATTN: KARL-ERIK BACKLUND PHONE NO : 461 816 3775
BOX 6460 SE DECISION MADE: 24-AUG-07
UPPSALA, SWEDEN SE-751 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMAPAC LUBRICATING JELLY
PHARMAPAC LLC 510(k) NO: K070623(TRADITIONAL)
ATTN: TOM OTTO PHONE NO : 601-743-9771
110 INDUSTRIAL PARK ROAD SE DECISION MADE: 31-AUG-07
DEKALB, MS 39329 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED,
PHAROS LIFE CORPORATION 510(k) NO: K070185(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 519 651 1177
11-380 JAMIESON PKWY SE DECISION MADE: 21-AUG-07
CAMBRIDGE, ONTARIO, CANADA N3C 4N4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
PHILIPS MEDICAL SYSTEMS 510(k) NO: K071564(TRADITIONAL)
ATTN: RICK SCHUL PHONE NO : 978-659-2622
3000 MINUTEMAN RD. SE DECISION MADE: 31-AUG-07
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K072070(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 497 031 4632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 10-AUG-07
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMCASET-P SAFETY IV CATHETER
PITANGO MEDICAL LTD 510(k) NO: K070020(TRADITIONAL)
ATTN: BEN LEVIN PHONE NO : 972 3 6130480
3A JABOTINSKI ST, 28TH FLOOR SE DECISION MADE: 16-AUG-07
DIAMOND HOUSE-DORON LEVY 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT GAN, ISRAEL 52520
DEVICE: CERAMIC BALL HEADS, 28, 32 AND 36 MM
PLUS ORTHOPEDICS AG 510(k) NO: K070928(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BRIDIE LANE SE DECISION MADE: 01-AUG-07
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
POINTE CONCEPTION MEDICAL, INC 510(k) NO: K071756(TRADITIONAL)
ATTN: WILLIAM C HAACK PHONE NO : 805-884-0403
121 E. MASON STREET SE DECISION MADE: 15-AUG-07
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDPOR ATTRACTOR IMPLANT
POREX SURGICAL, INC. 510(k) NO: K071335(TRADITIONAL)
ATTN: JERRI L DAVIS PHONE NO : 678-479-1610
15 DART RD. SE DECISION MADE: 08-AUG-07
NEWNAN, GA 30265 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
POSSIS MEDICAL, INC. 510(k) NO: K071336(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 24-AUG-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
POWER PRODUCTS, INC.-SPLINTEK 510(k) NO: K071404(TRADITIONAL)
ATTN: MALANIE HASEK PHONE NO : 913-410-2357
9755 RIDGE DRIVE SE DECISION MADE: 17-AUG-07
LENEXA, KS 66219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K071949(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 01-AUG-07
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTORY THREE WHEEL SCOOTER, MODEL: SC610
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K072165(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 17-AUG-07
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
PROSURG, INC. 510(k) NO: K071138(TRADITIONAL)
ATTN: ASHVIN DESAI PHONE NO : 408-945-4044
2195 TRADE ZONE BLVD. SE DECISION MADE: 15-AUG-07
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
PULMONETIC SYSTEMS, INC. 510(k) NO: K070594(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305
17400 MEDINA ROAD SE DECISION MADE: 01-AUG-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: QUANTUM DIREX SYSTEM
QUANTUM MEDICAL IMAGING, LLC. 510(k) NO: K072010(TRADITIONAL)
ATTN: MARK CAMIRAND PHONE NO : 631-567-5800
2002-B ORVILLE DRIVE NORTH SE DECISION MADE: 07-AUG-07
RONKONKOMA, NY 11779-7661 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
R & D SYSTEMS, INC. 510(k) NO: K072096(SPECIAL)
ATTN: NANCY C RING PHONE NO : 612-656-4533
614 MCKINLEY PL., N.E. SE DECISION MADE: 20-AUG-07
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005
R4 VASCULAR, INC. 510(k) NO: K071361(TRADITIONAL)
ATTN: MICHAEL SARAJIAN PHONE NO : 201-394-2708
1246 UNIVERSITY AVENUE WEST SE DECISION MADE: 20-AUG-07
SUITE 438 510(k) SUMMARY AVAILABLE FROM FDA
ST. PAUL, MN 55104
DEVICE: RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS
RAINBOW COMMUNICATIONS, INC 510(k) NO: K070338(TRADITIONAL)
ATTN: LEON E JEW PHONE NO : 510-785-9588
24301 SOUTHLAND DR., SUITE 405 SE DECISION MADE: 28-AUG-07
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K071509(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 08-AUG-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
REX MEDICAL 510(k) NO: K071422(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD. SE DECISION MADE: 22-AUG-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: FIRSTVIEW
RIVERAIN MEDICAL GROUP,LLC 510(k) NO: K071492(TRADITIONAL)
ATTN: JENNIFER STEINKE PHONE NO : 937-425-6811
3020 SOUTH TECH BLVD. SE DECISION MADE: 28-AUG-07
MIAMISBURG, OH 45342-4860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC (BODY COMPOSITION SOFTWARE)
RJL SYSTEMS, INC. 510(k) NO: K070999(TRADITIONAL)
ATTN: BARRY CALLAHAN PHONE NO : 586-790-0200
33939 HARPER AVE. SE DECISION MADE: 02-AUG-07
CLINTON TWP, MI 48035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTX3370
RTX HEALTHCARE A/S 510(k) NO: K071953(SPECIAL)
ATTN: NIELS O ANDERSON PHONE NO : 45 963 22300
STROEMMEN 6 SE DECISION MADE: 08-AUG-07
NOERRESUNDBY, DENMARK DK-9400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF-LIGHT DISPOSABLE ANOSCOPE
SAPIMED S.P.A. 510(k) NO: K070913(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN, SUITE A SE DECISION MADE: 10-AUG-07
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMAX NEWTRON XS
SATELEC-ACTEON GROUP 510(k) NO: K071424(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 24-AUG-07
MT LAUREL, NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
SCHUTZ-DENTAL GMBH 510(k) NO: K071010(TRADITIONAL)
ATTN: MICHAEL WIERZ PHONE NO : 49 600 3814620
DIESELSTRASSE 5-6 SE DECISION MADE: 24-AUG-07
ROSBACH, HESSEN, GERMANY D-61191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEFIELD ANALYZER
SEEING MACHINES LIMITED 510(k) NO: K063310(TRADITIONAL)
ATTN: ALAN DONALD PHONE NO : 858-458-8584
11440 WEST BERNARDO CT. SE DECISION MADE: 02-AUG-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92127-1644
DEVICE: OASIS RELEASE 1.0
SEGAMI CORPORATION 510(k) NO: K071584(TRADITIONAL)
ATTN: PHILIPPE BRIANDET PHONE NO : 410-381-2311
8325 GUILFORD RD., SUITE B SE DECISION MADE: 31-AUG-07
COLUMBIA, MD 21046 510(k) STATEMENT
DEVICE: SENTINEL LITHIUM ASSAY
SENTINEL CH SPA 510(k) NO: K070987(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448
VIA ROBERT KOCH 2 SE DECISION MADE: 02-AUG-07
MILAN, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMI
SHANGHAI CHINA STAR CORP 510(k) NO: K071072(TRADITIONAL)
ATTN: ROMIL RAMBHIA PHONE NO : 516-482-9001
55, NORTHERN BLVD. SUITE 200 SE DECISION MADE: 30-AUG-07
GREAT NECK, NY 11001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAR-9400F
SHIMADZU CORP. 510(k) NO: K072006(ABBREVIATED)
ATTN: DON KARLE PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 31-AUG-07
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30
SHINCHANG MEDICAL CO., LTD. 510(k) NO: K070988(TRADITIONAL)
ATTN: JAN J FRANK PHONE NO : 801-863-0975
3762 SOUTH 150 EAST SE DECISION MADE: 23-AUG-07
SALT LAKE CITY, UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIFIL II
SHOFU DENTAL CORP. 510(k) NO: K071742(TRADITIONAL)
ATTN: DAVID MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 15-AUG-07
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: ADVIA CHEMISTRY ENZYMATIC CREATININE_2
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K070727(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVENUE SE DECISION MADE: 03-AUG-07
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM LUMINOS DRF
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K062623(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PKWY. SE DECISION MADE: 22-AUG-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM ESSENZA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071925(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 14-AUG-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072266(TRADITIONAL)
ATTN: SHEILA PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 29-AUG-07
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SBI STAFIX
SMALL BONE INNOVATIONS INC. 510(k) NO: K071479(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 02-AUG-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI TITANIUM THREADED PIN
SMALL BONE INNOVATIONS INC. 510(k) NO: K071540(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 08-AUG-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI RHEAD PLATING SYSTEM
SMALL BONE INNOVATIONS INC. 510(k) NO: K071549(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 07-AUG-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI ARTFIX
SMALL BONE INNOVATIONS INC. 510(k) NO: K071656(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 27-AUG-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI FOREFOOT SET
SMALL BONE INNOVATIONS, INC. 510(k) NO: K063635(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVENUE SE DECISION MADE: 29-AUG-07
14TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: BIORAPTOR 2.3 PK SUTURE ANCHOR
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K071586(TRADITIONAL)
ATTN: JULIE ACKER PHONE NO : 508-261-3618
150 MINUTEMAN RD. SE DECISION MADE: 17-AUG-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLEVYN AG DRESSING
SMITH & NEPHEW, INC. 510(k) NO: K063835(TRADITIONAL)
ATTN: TERRY MCMAHON PHONE NO : 727-392-1261
11775 STARKEY RD. SE DECISION MADE: 03-AUG-07
LARGO, FL 33773-4727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K071563(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS ROAD SE DECISION MADE: 08-AUG-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURN
SMITH & NEPHEW, INC. 510(k) NO: K071790(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 BROOKS RD. SE DECISION MADE: 17-AUG-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
SMITHS MEDICAL ASD, INC. 510(k) NO: K071269(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-889-2220
6250 SHIER RINGS RD. SE DECISION MADE: 01-AUG-07
DUBLIN, OH 40316 510(k) STATEMENT
DEVICE: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO
SMITHS MEDICAL ASD, INC. 510(k) NO: K071785(ABBREVIATED)
ATTN: BRIAN FARIAS PHONE NO : 603-357-3812
10 BOWMAN DR. SE DECISION MADE: 02-AUG-07
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEMO 3D SEMIRIGID ANNULOPLASTY RING
SORIN BIOMEDICA CARDIO S.R.L. 510(k) NO: K071327(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 512-435-3266
1300 EAST ANDERSON LANE SE DECISION MADE: 10-AUG-07
AUSTIN, TX 78752-1793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PXS-810, PODIATRY X-RAY SYSTEM
SOURCE-RAY, INC. 510(k) NO: K071392(TRADITIONAL)
ATTN: RAY MANEZ PHONE NO : 631-244-8200
167 KEYLAND CT. SE DECISION MADE: 03-AUG-07
BOHEMIA, NY 11716 510(k) STATEMENT
DEVICE: M3 MONITOR
SPECTRUM MEDICAL LTD 510(k) NO: K072131(TRADITIONAL)
ATTN: STEVE TURNER PHONE NO : 440 123 2650121
HARRIER 4,METEOR BUSINESS PARK SE DECISION MADE: 17-AUG-07
CHELTENHAM ROAD EAST 510(k) SUMMARY AVAILABLE FROM FDA
GLOUCESTER, GLOUCESTERHSIRE, UNITETHIRD PARTY REVIEW
DEVICE: PSS SYSTEM
SPINAL USA 510(k) NO: K071438(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244
644 LAKELAND EAST DR., STE. A SE DECISION MADE: 21-AUG-07
FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLEXION SPIRAL VARIABLE RADIUS CATHETER
ST. JUDE MEDICAL 510(k) NO: K072012(SPECIAL)
ATTN: LAURA MOEN-FTACEK PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 22-AUG-07
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STD MED PRIMO PORT
STD MED, INC. 510(k) NO: K070911(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 10-AUG-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
STEREOTAXIS, INC. 510(k) NO: K071029(TRADITIONAL)
ATTN: DENNIS POZZO PHONE NO : 314-678-6136
4320 FOREST PARK AVENUE SE DECISION MADE: 24-AUG-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ST. LOUIS, MO 63108
DEVICE: STRYKER EXTERNAL FIXATION SYSTEM
STRYKER CMF 510(k) NO: K071628(TRADITIONAL)
ATTN: TENNILLE FOLK PHONE NO : 877-534-2464
750 TRADE CENTRE WAY SE DECISION MADE: 10-AUG-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
KALAMAZOO, MI 49001
DEVICE: STRYKER SPINE XIA III SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K071373(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 27-AUG-07
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL
SURGICAL SPECIALTIES CORP. 510(k) NO: K071989(TRADITIONAL)
ATTN: KEVIN BENTLEY PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 06-AUG-07
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
SURGICAL SPECIALTIES CORP. 510(k) NO: K072028(TRADITIONAL)
ATTN: LOIS SMART PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 03-AUG-07
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HY
SWISS AMERICAN PRODUCTS, INC. 510(k) NO: K071703(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 972-385-2900
2055 LUNA RD., STE. 126 SE DECISION MADE: 22-AUG-07
CARROLLTON, TX 75006 510(k) STATEMENT
DEVICE: VELASHAPE
SYNERON MEDICAL LTD. 510(k) NO: K071872(TRADITIONAL)
ATTN: YONI IGER PHONE NO : 972 732 442200
POB 550 SE DECISION MADE: 22-AUG-07
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
SYNTHES (USA) 510(k) NO: K071476(TRADITIONAL)
ATTN: ANGELA SILVESTRI PHONE NO : 484-356-9728
1301 GOSHEN PKWY SE DECISION MADE: 24-AUG-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TALON AND REVERE
TALON ACRYLICS, INC. 510(k) NO: K071245(TRADITIONAL)
ATTN: SHERMAN WATSON PHONE NO : 503-262-9307
850 N.E. 102ND AVE. SE DECISION MADE: 02-AUG-07
PORTLAND, OR 97220-4007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
TANGSHAN HONGYUN PLASTIC PRODUCTS 510(k) NO: K072001(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG. 1, SE DECISION MADE: 15-AUG-07
JIANZIANG YUAN NO 209 BEI SI 510(k) SUMMARY AVAILABLE FROM FDA
HUAN ZHONG, ROA; BEIJING, CHINA 10008
DEVICE: DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
TECHNOMED EUROPE 510(k) NO: K063729(TRADITIONAL)
ATTN: MAURICE ROOST PHONE NO : 31 43 4086868
AMERIKALAAN 71 SE DECISION MADE: 21-AUG-07
MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
TECNIMED S.R.L. 510(k) NO: K072108(SPECIAL)
ATTN: MARIA F GRIFFIN PHONE NO : 631-421-4587
55 NORTHERN BLVD. SE DECISION MADE: 31-AUG-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ORTHOMEND SOFT TISSUE MATRIX
TEI BIOSCIENCES INC. 510(k) NO: K071807(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 06-AUG-07
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATMARKER TIME TEMPERATURE INDICATOR
TEMPTIME CORPORATION 510(k) NO: K063759(TRADITIONAL)
ATTN: RICHARD PHILLIPS PHONE NO : 301-272-3115
116 AMERICAN ROAD SE DECISION MADE: 15-AUG-07
MORRIS PLAINS, NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGEN PEARL BRAND ZIRCONIA
THE ARGEN CORPORATION 510(k) NO: K071410(TRADITIONAL)
ATTN: PAUL CASCONE PHONE NO : 858-455-7900
5855 OBERLIN DR. SE DECISION MADE: 15-AUG-07
SAN DIEGO, CA 92121-4718 510(k) STATEMENT
DEVICE: CORAL PEDICLE SCREW SYSTEM
THEKEN SPINE LLC 510(k) NO: K070962(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 22-AUG-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH C
THERMO ELECTRON OY 510(k) NO: K063086(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 32910762
RATASTIE 2 SE DECISION MADE: 08-AUG-07
PO BOX 100 510(k) STATEMENT
VANTAA, FINLAND FIN-01621
DEVICE: CRYOSEAL FS APPLICATOR SYSTEM
THERMOGENESIS CORP. 510(k) NO: K071126(TRADITIONAL)
ATTN: JOHN CHAPMAN PHONE NO : 916-858-5132
2711 CITRUS RD. SE DECISION MADE: 16-AUG-07
RANCHO CORDOVA, CA 95742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATITUDE ELBOW PROTHESIS
TORNIER 510(k) NO: K070787(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898
161 RUE LAVOISIER SE DECISION MADE: 24-AUG-07
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K072065(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 14-AUG-07
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.3M MONOCHROME LCD MONITOR MDL1908A
TOTOKU ELECTRIC CO., LTD 510(k) NO: K072066(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA SE DECISION MADE: 14-AUG-07
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
TPC ADVANCED TECHNOLOGY, INC. 510(k) NO: K071485(TRADITIONAL)
ATTN: SCOTT BECKLEY PHONE NO : 626-810-4337
18525 EAST GALE AVE. SE DECISION MADE: 28-AUG-07
CITY OF INDUSTRY, CA 91748 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUNDSTAT, MODEL TC1001
TRAUMACURE INC. 510(k) NO: K071936(TRADITIONAL)
ATTN: CAMPBELL HUTTON PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVE. SE DECISION MADE: 23-AUG-07
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
UROPLASTY, INC. 510(k) NO: K071822(TRADITIONAL)
ATTN: LISA GALLATIN PHONE NO : 952-426-6158
5420 FELTL RD. SE DECISION MADE: 20-AUG-07
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
VARIAN MEDICAL SYSTEMS 510(k) NO: K071992(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 15-AUG-07
M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304-1129
DEVICE: MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K071873(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY, E-110 SE DECISION MADE: 09-AUG-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K070938(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4380
6464 SYCAMORE COURT NORTH SE DECISION MADE: 06-AUG-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
VASCULAR SOLUTIONS, INC. 510(k) NO: K072117(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4380
6464 SYCAMORE COURT SE DECISION MADE: 29-AUG-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERSCREEN PNEUMO & MASTERSCOPE
VIASYS HEALTHCARE GMBH 510(k) NO: K071753(SPECIAL)
ATTN: YVETTE LLOYD PHONE NO : 714-919-3247
22745 SAVI RANCH PKWY. SE DECISION MADE: 14-AUG-07
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
VISION-SCIENCES, INC. 510(k) NO: K071903(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 02-AUG-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOS
VISION-SCIENCES, INC. 510(k) NO: K072073(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 29-AUG-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROC
VISION-SCIENCES, INC. 510(k) NO: K072088(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 29-AUG-07
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
VITALCOR, INC. 510(k) NO: K070661(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 29-AUG-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL
VOLCANO CORPORATION 510(k) NO: K071660(SPECIAL)
ATTN: JENNIFER MOTTO PHONE NO : 916-231-4509
2870 KILGORE RD. SE DECISION MADE: 31-AUG-07
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDI CO2 EASY
WESTMED, INC. 510(k) NO: K072220(TRADITIONAL)
ATTN: DALE BICKLEY PHONE NO : 520-294-7987
5580 S. NOGALES HIGHWAY SE DECISION MADE: 23-AUG-07
TUCSON, AZ 85706 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K070754(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-576-0133
10 POMEROY RD. SE DECISION MADE: 31-AUG-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 287
TOTAL WITH SUMMARIES 265
TOTAL WITH STATEMENTS 22
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