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
Updated September 5, 2007
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