FDA 510(k) Decisions During August, 1976  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K760442 08/26/1976 NEBULIZER ADAPTER (AERMIST) AERWAY LABORATORIES, INC.
K760158 08/19/1976 NEEDLES AND SUTURES, SILK & NYLON ALCON LABORATORIES
K760451 08/30/1976 AIR WATER SOURCE (ACMI MODEL 710) AMERICAN CYSTOCOPE MAKERS, INC.
K760452 08/30/1976 COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) AMERICAN CYSTOCOPE MAKERS, INC.
K760210 08/11/1976 BLANKET, WATER-JEL FIRE AMERICAN SAFETY
K760280 08/23/1976 ELECTRODE SERIES 1401 ANDOVER MEDICAL, INC.
K760358 08/23/1976 ELECTRODE SERIES 1600 ANDOVER MEDICAL, INC.
K760421 08/23/1976 THERMOMETER, SURVALENT-ELECTRONIC ARBROOK MFG. CORP.
K760042 08/30/1976 BLOOD TUBING SETS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760054 08/03/1976 CULTURE TUBE, (VACUTAINER) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760063 08/03/1976 SPECIMEN COLLECTOR, ANAEROBIC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760040 08/03/1976 TEST, MONO., CARD (MACRO-VUE) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760043 08/03/1976 TEST, RHEUM. ARTH., CARD (MACRO-VUE) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760393 08/23/1976 BED PAN, STACKABLE (AUTOCLAVABLE) BEMIS HEALTH CARE
K760165 08/06/1976 FILTER, INFUSION BLOOD (1 PFF-100) BENTLEY LABORATORIES, INC.
K760162 08/04/1976 HEMATOLOGY CONTROL BIOLOGICAL CORP. OF AMERICA
K760445 08/26/1976 DENTAL PROPHYLAXIS UNIT ULTRASONIC BRANSON ULTRASONICS CORP.
K760265 08/23/1976 ELCTROCARDIOGRAPH, EK-6 BURDICK CORP.
K760275 08/11/1976 TREADMILL (TMS-300) BURDICK CORP.
K760204 08/04/1976 BUTTONS, PMMA (FOR CONTACT LENSES) BURTON PARSONS & CO., INC.
K760093 08/23/1976 CATHETER, SILICONE FOLEY (BARDEX) C.R. BARD, INC.
K760455 08/26/1976 OBSTETRICAL PACK (VIGILON OB PACK) C.R. BARD, INC.
K760217 08/23/1976 SUCTION INSTRUMENT, MACBICK DIS. FRAZ. C.R. BARD, INC.
K760216 08/23/1976 SUCTION INSTRUMENT, MACBICK POOLE TIP C.R. BARD, INC.
K760254 08/23/1976 TRAY, FOLEY CATHETER C.R. BARD, INC.
K760253 08/23/1976 TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG C.R. BARD, INC.
K760228 08/06/1976 ANESTHESIA MACHINE, CHEMETRON CHEMETRON HEALTH SYSTEMS
K760256 08/11/1976 TEST SYSTEM, RIA CORTISOL CORNING MEDICAL & SCIENTIFIC
K760196 08/03/1976 ASSAY, AMPHET. NDC#11711-0127-1 COULTER COULTER ELECTRONICS, INC.
K760194 08/03/1976 NDC#12739-0010-1 C-ZYME GPT COULTER ELECTRONICS, INC.
K760193 08/03/1976 NDC#12739-0011-1 C-ZYME GOT COULTER ELECTRONICS, INC.
K760195 08/03/1976 REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 COULTER ELECTRONICS, INC.
K760422 08/23/1976 SURGICAL RETRACTOR CUTTER LABORATORIES, INC.
K760318 08/03/1976 ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760416 08/23/1976 DATA-TOPE SYSTEM DIGOXIN RIA DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760248 08/09/1976 GLOVES, APARTICULATE SURGICAL DEKNATEL, INC.
K760311 08/09/1976 INSTRUMENTS, GENERAL HAND & SURGERY DEPUY, INC.
K760334 08/11/1976 PROSTEHSIS, TOTAL KNEE REPLACEMENT DEPUY, INC.
K760326 08/04/1976 SURGICAL INSTRUMENTS, OPTHALMIC DEPUY, INC.
K760325 08/03/1976 SURGICAL INSTRUMENTS, ORTHOPEDIC DEPUY, INC.
K760328 08/11/1976 RAZOR, DISPOSABLE DEVON INDUSTRIES, INC.
K760262 08/03/1976 RADIOASSY KIT, 3H-FOLATE DIAMOND SHAMROCK CORP.
K760420 08/23/1976 FILTER, VACUUM LINE LINEGUARD DIEMOLDING CORP.
K760371 08/13/1976 VENT-O2-CATH DRYDEN CORP.
K760167 08/06/1976 BAG, POST OPERATIVE LUNG EXERCIZING BLOW DYTEK CORP.
K760168 08/09/1976 PENCIL, ELECTROSURGICAL DYTEK CORP.
K760151 08/26/1976 APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) EDWARDS LABORATORIES
K760263 08/04/1976 I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) FOREGGER
K760097 08/03/1976 FEBRILE ANTIGENS & CONTROL SERUMS GAMMA BIOLOGICALS, INC.
K760096 08/03/1976 REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O GAMMA BIOLOGICALS, INC.
K760098 08/03/1976 REAGENT, VDRL GAMMA BIOLOGICALS, INC.
K760033 08/03/1976 TEST, ANTIBODIES FOR GRP A, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760035 08/03/1976 TEST, C-REATIVE PROTEIN, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760036 08/03/1976 TEST, LATEX SLIDE, RHEUMATOID FACTOR GAMMA BIOLOGICALS, INC.
K760032 08/03/1976 TEST, MONO., DIFFERENTIAL SLIDE GAMMA BIOLOGICALS, INC.
K760034 08/11/1976 TEST, STREP, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760315 08/11/1976 PAD, POLYETHER FOAM, OPEN CELL GAYMAR INDUSTRIES, INC.
K760466 08/26/1976 TABLE, X-RAY, RFX CLASSICAL GENERAL ELECTRIC CO.
K760485 08/30/1976 HEMASTAIN FIXATIVE GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760487 08/30/1976 HEMASTAIN PHOSPHATE BUFFER GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760486 08/30/1976 HEMASTAIN WRIGHT STAIN GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760024 08/26/1976 ULTRAZYME ALKALINE PHOSPHATASE HARLECO
K760025 08/26/1976 ULTRAZYME GT HARLECO
K760023 08/26/1976 ULTRAZYME HBD HARLECO
K760314 08/04/1976 FLOWMETER, OXYGEN HARRIS-LAKE, INC.
K760317 08/04/1976 REGULATORS, HIGH SUCTION HARRIS-LAKE, INC.
K760316 08/04/1976 REGULATORS, LOW SUCTION HARRIS-LAKE, INC.
K760464 08/30/1976 PHON/STRESS SYSTEM (#21126A) HEWLETT-PACKARD CO.
K760465 08/30/1976 STRESS SYSTEM, 3-CHANNEL (#21127A) HEWLETT-PACKARD CO.
K760463 08/30/1976 STRESS SYSTEM, SINGLE-CHANNEL (#21125) HEWLETT-PACKARD CO.
K760501 08/30/1976 VALVE, STANDARD MODEL PUDENZE FLUSHING HEYER SCHULTE CORP.
K760372 08/13/1976 HUMIDIFIER, DISPOSABLE HOSPITEK
K760454 08/26/1976 GOUFFON PIN, ADJUSTABLE HOWMEDICA CORP.
K760354 08/11/1976 TEST, SLIDE FOR C-REATIVE PROTEIN ICL SCIENTIFIC
K760330 08/04/1976 CANNULA, DISPOSABLE OXYGEN TTHERAPY INHAL-O-TECH MEDICAL PLASTIC
K760313 08/04/1976 KIT, PREP, INSPIRON IV INSPIRON CORP.
K760461 08/26/1976 NOSE CLIP INSPIRON CORP.
K760211 08/26/1976 ANALYZER, GLUCOSE/UREA/CREATININE INSTRUMENTATION LABORATORY CO.
K760232 08/26/1976 PRINTER, IL 460 INSTRUMENTATION LABORATORY CO.
K760448 08/27/1976 SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT INSTRUMENTATION LABORATORY CO.
K760233 08/26/1976 TABLE, SAMPLE IL 461 INSTRUMENTATION LABORATORY CO.
K760206 08/03/1976 TEST, DETECTION, ANTINUCLEAR ANTIBODIES INTL. DIAGNOSTIC TECHNOLOGY
K760426 08/26/1976 TAMPON, PLAYTEX 2 VERSION B INTL. PLAYTEX, INC.
K760401 08/26/1976 COCAINE KIT, TOXI-PAK J.T. BAKER CHEMICAL CO.
K760399 08/26/1976 REAGENT, P-NITROPHENYL PHOSPHATE J.T. BAKER CHEMICAL CO.
K760319 08/11/1976 KIT, CATHETER JELCO LABORATORIES
K760022 08/09/1976 NEEDLE, FILTER JELCO LABORATORIES
K760502 08/30/1976 VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. JOE W. UTT
K760277 08/11/1976 UNDERPAD CODE NO. 8453 JOHNSON & JOHNSON PROFESSIONALS, INC.
K760396 08/26/1976 TEST, MACROGLOBULIN KIT (ALPHA2) KALLESTAD LABORATORIES, INC.
K760343 08/11/1976 TRAY, CURITY CONTINUOUS EPIDURAL KENDALL RESEARCH CENTER
K760400 08/23/1976 BONDING AGENT, VYTOL L.D. CAULK CO.
K760378 08/23/1976 CEMENT, RESIN DENTAL (AUTO-TACH) L.D. CAULK CO.
K760376 08/23/1976 CEMENT, RESIN DENTAL (SOLO-TACH) L.D. CAULK CO.
K760379 08/23/1976 DENTAL AMALGAM ALLOY (SPHERICAL II) L.D. CAULK CO.
K760377 08/23/1976 FILLING, RESIN DENTAL (VYTOL) L.D. CAULK CO.
K760405 08/23/1976 SEALANT, NEW FILLED L.D. CAULK CO.
K760418 08/23/1976 9075 LEE PHARMACEUTICALS
K760419 08/23/1976 ADHESION PROMOTOR LEE PHARMACEUTICALS
K760324 08/03/1976 BONDING AGENT, PRESTIGE LEE PHARMACEUTICALS
K760417 08/23/1976 LEE-FILL ULTRAVIOLET-CURED REST. MAT. LEE PHARMACEUTICALS
K760331 08/11/1976 TURBINE, AIR DRIVEN HANDPIECE (2000) LITTON DENTAL PRODUCTS
K760199 08/04/1976 ELECTRORETINOGRAPH LKC TECHNOLOGIES, INC.
K760051 08/30/1976 TRAY, SUTURE REMOVAL M-C IND., INC.
K760279 08/13/1976 X-RAY FILM, CONVEY OR SYSTEM MALLINCKRODT GROUP, INC.
K760218 08/03/1976 CANNULAE, PLASTIC DISPOSABLE NASAL MANNER MEDICAL PRODUCTS
K760221 08/03/1976 I.P.P.B., DIS. W/MANIFOLD/NEBULIZER MANNER MEDICAL PRODUCTS
K760219 08/03/1976 MASKA, OXYGEN VINYL D-SP. SINGLE USE MANNER MEDICAL PRODUCTS
K760220 08/03/1976 TUBING, SINGLE USE OXYGEN SUPPLY MANNER MEDICAL PRODUCTS
K760504 08/26/1976 PLETHYSMOGRAPH (MDI SYSTEM II) MARKETING DEVELOPMENT INTL.
K760443 08/26/1976 CARDIAC ELECTRODE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760242 08/11/1976 PROBECOT II MEASUREMENT-SCIENCE CORP.
K760508 08/30/1976 ACCUTAPE 24 MEDCRAFT CORP.
K760510 08/30/1976 MONITORING SYSTEM, REHABILITATION MEDCRAFT CORP.
K760509 08/30/1976 TREADMILL, DIAGNOSTIC MEDCRAFT CORP.
K760278 08/30/1976 SLIDE, LAB-TEK COVERED MICRO MILES LABORATORIES, INC.
K760341 08/11/1976 HUMIDIFIER, ELECTRONIC (EH147) MISTOGEN EQUIPMENT CO.
K760352 08/11/1976 CIRCUIT, INTENSIVE CARE VENTILATOR MONAGHAN MEDICAL CORP.
K760312 08/04/1976 ELECTRODE, PNS NDM CORP.
K760088 08/06/1976 ANALYZER, SENTORR BLOOD GAS OHIO MEDICAL PRODUCTS
K760230 08/06/1976 VALVE, PEEP OHIO MEDICAL PRODUCTS
K760402 08/23/1976 SYRINGE SET, 3-WAY THERMODILUTIN OMP LABORATORIES, INC.
K760234 08/23/1976 OXIMETER, IN VIVO CATHETER OXIMETRIX, INC.
K760342 08/11/1976 RAZOR, SCHICK DISPOSABLE PARKE-DAVIS CO.
K760404 08/23/1976 BI-CENTRIC SYSTEM PELTON & CRANE CO.
K760237 08/11/1976 GOWN, BOUNDARY SINGLE USE REINFORCED PROCTER & GAMBLE MFG. CO.
K760213 08/09/1976 LENSES, CONTACT, POLYMETHYL METHACRYLATE PROGRESSIVE AFFILIATED LABS, INC.
K760244 08/23/1976 RADIOEAR, PERSONAL RADIOEAR CORP.
K760335 08/11/1976 NEBULIZER, MICRO (ADDI-MIST) RESPIRATORY CARE, INC.
K760257 08/09/1976 SPONGE, RICHARDS WOUND DRAINAGE SYSTEM RICHARD'S MEDICAL EQUIP., INC.
K760337 08/11/1976 CANNULA, ARGYLE NASAL OXYGEN SHERWOOD MEDICAL INDUSTRIES
K760351 08/23/1976 CATHETER, ARGYLE THORACIC SHERWOOD MEDICAL INDUSTRIES
K760246 08/04/1976 ENDOTRACHEAL T CONNECTOR SHERWOOD MEDICAL INDUSTRIES
K760338 08/11/1976 MONITOR, RESP. OXYGEN (TOP) SHERWOOD MEDICAL INDUSTRIES
K760340 08/11/1976 RESPIRATORY SUPPORT SYSTEM, NEONATAL SHERWOOD MEDICAL INDUSTRIES
K760247 08/26/1976 GLUCOSE REAGENT SYS, SIGMA PROCED. 115 SIGMA CHEMICAL CO.
K760332 08/23/1976 SIGMA AMMONIA REAGENT SIGMA CHEMICAL CO.
K760055 08/26/1976 REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER SMITH KLINE DIAGNOSTICS, INC.
K760413 08/23/1976 TAPE, LIGHTCAST II WB SOLAR LABORATORIES, INC.
K760004 08/23/1976 SYRINGE, DISPOSABLE, ALL PLASTIC STEWART-NAUMANN LABORATORIES
K760005 08/23/1976 SYRINGE, DISPOSABLE, GLASS & PLASTIC STEWART-NAUMANN LABORATORIES
K760212 08/11/1976 DRAPES, BARRIER, STERILE PATIENT READY SURGIKOS, INC.
K760222 08/06/1976 FILTER, TRANSFUSION BLOOD, INTERSEPT SURGIKOS, INC.
K760307 08/11/1976 BEDPAN, SINGLE PATIENT USE, TECNOL TECNOL NEW JERSEY WOUND CARE, INC.
K760308 08/11/1976 I.V. SUPPORT, TECNOL ARMBOARD TECNOL NEW JERSEY WOUND CARE, INC.
K760309 08/09/1976 LIMB HOLDER, TECNOL REMINDER TECNOL NEW JERSEY WOUND CARE, INC.
K760229 08/26/1976 ACID BASE SYSTEM, RADIOMETER AUTOMATED THE LONDON CO.
K760322 08/03/1976 CHAIR, ATTACHED INSTRUMENT DEL. SYS. THE S. S. WHITE CO.
K760321 08/03/1976 CHAIR, DENTAL OPERATIVE THE S. S. WHITE CO.
K760369 08/11/1976 POWDERLITE THE S. S. WHITE CO.
K760323 08/03/1976 X-RAY UNIT, DENTAL DIAGNOSTIC THE S. S. WHITE CO.
K760259 08/23/1976 CATHETER 3-WAY SILICONE FOLEY TRAVENOL LABORATORIES, S.A.
K760243 08/03/1976 GLOVES, STERILE LATEX SURGEON'S TRAVENOL LABORATORIES, S.A.
K760249 08/04/1976 TRAY, STERILE DISPOSABLE ARTHROGRAM TRAVENOL LABORATORIES, S.A.
K760403 08/23/1976 TEMPORARY ATRIAL ELECTRODE KIT USCI, DIV. C.R. BARD, INC.
K760174 08/30/1976 ADAPTER, RESECTOSCOPE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760186 08/04/1976 DISSECTOR, TROUTMAN CORNEAL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760175 08/30/1976 DRAPE, TRANSURETHRAL RESECTION (TUR) V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760176 08/30/1976 FLOORSTAND, FIBER OPTIC LIGHT SOURCE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760191 08/04/1976 KNIFE, TROUTMAN CORNEAL LARGE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760187 08/04/1976 KNIFE, TROUTMAN CORNEAL SMALL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760190 08/04/1976 SCISSORS, IRIS STRAIGHT V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760188 08/04/1976 SCISSORS, MICRO IRIS CURVED V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760185 08/04/1976 SCISSORS, MICRO IRIS STRAIGHT V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760177 08/30/1976 TELESCOPE, RIGID ENDOSCOPE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760274 08/30/1976 TIP, RUBBER, PERFORATED V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760370 08/23/1976 INFUSION EQUIPMENT, INTRAVENOUS VALLEYLAB, INC.
K760429 08/23/1976 FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. VARIAN ASSOC., INC.
K760444 08/26/1976 PHOTOCOAGULATOR, LOG 3 PORTABLE XENON VARIAN ASSOC., INC.
K760365 08/11/1976 BLANKET, BURN WINN HIRSCH & ASSOC.


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