FDA 510(k) Decisions During August, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K771253 08/25/1977 HEMOX-ANALYZER 3M COMPANY
K771499 08/16/1977 FLEXIBLE ARTERIAL CANNULAE 3M HEALTH CARE, SARNS
K770244 08/04/1977 AUTO DIFFERENTIAL CELL COUNTER SYSTEM ABBOTT LABORATORIES
K771129 08/04/1977 AUTO-LOGIC II SYSTEM ABBOTT LABORATORIES
K771345 08/04/1977 BICHROMATIC ANALYZER ABA-200 ABBOTT LABORATORIES
K771365 08/16/1977 CREATININE ANALYSIS PRODUCTS ABBOTT LABORATORIES
K771235 08/03/1977 HTSH RIA HUMAN THYROID HORMONE RIA ABBOTT LABORATORIES
K771321 08/03/1977 HYDRON BURN BANDAGE ABBOTT LABORATORIES
K771228 08/02/1977 LIFECARE EMPTY CONTAINER ABBOTT LABORATORIES
K771309 08/03/1977 RIA FOR TOTAL THYROXINE ABBOTT LABORATORIES
K771236 08/03/1977 TRIOBEAD-125 DIAGNOSTIC KIT ABBOTT LABORATORIES
K771301 08/04/1977 DIGITAL RADIATION DETECTOR ACTUS, INC.
K771433 08/19/1977 AUTO. DEVEL. UNIT FOO DENTAL X-RAY ADA PRODUCTS CO., INC.
K771150 08/04/1977 COPPER KETTLE VAPORIZER PLUS AIR PRODUCTS & CHEMICALS, INC.
K771350 08/19/1977 AMBU RESUSCITATOR AIR-SHIELDS, INC.
K771541 08/25/1977 FETAL MONITORING SYSTEM AIR-SHIELDS, INC.
K771528 08/16/1977 CATHETER, CARDIAC PACING, ENDOCARDIAL AMERICAN TECHNOLOGY, INC.
K771339 08/02/1977 MALE LUER LOCK PLUG AMERICAN VIGGO
K771266 08/02/1977 STEAM STERILIZER AMSCO HOSPITAL PRODUCTS CO.
K771008 08/03/1977 API 20C ANALYTICAL PRODUCTS, INC.
K771264 08/02/1977 FLOTATION THERAPY BED AQUARIUS MEDICAL SERVICES
K771260 08/03/1977 LINEAR ACCELERATOR G-2900 ATOMIC ENERGY OF CANADA
K771406 08/26/1977 GUTTA GUN AUS-TEX DENTAL MFG. & DESIGN
K771385 08/04/1977 2 JET SET BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771370 08/03/1977 ICROTAINEO BRAND TUBE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771489 08/22/1977 RTERIAL BLOOD SAMPLING KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771335 08/03/1977 CREATININE ANALYZER 2 BECKMAN INSTRUMENTS, INC.
K771534 08/26/1977 BIOTRON 18 BIOTRONICS CORP.
K771532 08/26/1977 SPIROMETEO & LUNG EXERCISER, 4601 BOEHRINGER LABORATORIES
K771497 08/22/1977 CK-MB BOEHRINGER MANNHEIM CORP.
K771562 08/25/1977 AGGLUTINATING SERUM W135 BURROUGHS WELLCOME CO.
K771261 08/16/1977 ADVANSET C.R. BARD, INC.
K771440 08/16/1977 MACBICK CONDUCTIVE GEL - 000907 C.R. BARD, INC.
K771074 08/04/1977 NASAL OXYGEN CANNULA, #017207 C.R. BARD, INC.
K771075 08/04/1977 OXYGEN CONNECTING TUBE #017205 C.R. BARD, INC.
K771577 08/26/1977 CLINICAL EMG MODEL 133 CALNOR OF EL PASEO, INC.
K771229 08/02/1977 STERILIZERS, 3100 SERIES TRIM LINE CASTLE CO.
K771368 08/04/1977 PORTABLE INFANT VENTILATOR CAVITRON CORP.
K771371 08/04/1977 SCREENING COMPUTEO SC-20 CAVITRON CORP.
K771201 08/22/1977 FORMALIN BUFFER CONCENTRATE CENTRAL LABS. ASSOC. MD PATHOLOGISTS
K771198 08/02/1977 LUMI-AGGREGOMETER CHRONO-LOG CORP.
K771615 08/30/1977 AUDI-SIL EARMOLD MATERIAL COE LABORATORIES, INC.
K771529 08/16/1977 PERITONEAL INTRODUCER & SHEATH CORDIS CORP.
K771323 08/10/1977 ELECTROPHORESIS OVEN THERMOMETER CORNING MEDICAL & SCIENTIFIC
K771303 08/22/1977 FLAME PHOTOMETER MODEL 460 CORNING MEDICAL & SCIENTIFIC
K771513 08/22/1977 KEM-O-MAT COULTER ELECTRONICS, INC.
K770776 08/04/1977 TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK CUTTER LABORATORIES, INC.
K770973 08/04/1977 CARDIOZYME CK CONTROL NORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770971 08/04/1977 CARDIOZYME CK-CONTROL ABNORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770974 08/26/1977 CARDIOZYME CK-MB REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771346 08/22/1977 CI-TROL COAGULATION CONTROLS II & III DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771138 08/04/1977 PIPETS BOROSILICATE GLASS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771137 08/04/1977 PIPETS UNIFORM DROP SIZE BOROSILICATE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771588 08/25/1977 PLATELET CONTROLS NORMAL & ABNORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770950 08/02/1977 WHOLE BLOOD GAS CONTROL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771607 08/25/1977 HEARING AID MODEL 775 DANAVOX, INC.
K771500 08/16/1977 PRESSUROMETER II DEL MAR AVIONICS
K771176 08/16/1977 GOTHIC ARCH TRACING DENTSPLY INTL.
K771039 08/05/1977 RESPIRATOR, PROTABLE, VOLUME CONTROLLED DEPT. OF THE NAVY
K771598 08/26/1977 PATELLA PROSTHESIS/TRAIL COMPONENT DEPUY, INC.
K771125 08/02/1977 POLYURETHANE PROD. FOR I.V. NEEDLES DEVON INDUSTRIES, INC.
K771485 08/16/1977 PET-TV X-RAY IMAGE INTENSIFIER SYSTEM DIAGNOSTIC INFORMATION, INC.
K771526 08/25/1977 125 I ALDOSTERONE RIA KIT DIAGNOSTIC PRODUCTS CORP.
K771034 08/04/1977 HI-MID CURCUIT DRAEGER MEDICAL, INC.
K771349 08/02/1977 MODIFICATION TO KIDNEY DIALYZER ERIKA, INC.
K771120 08/03/1977 IMPREFLEX ALGINATE IMPRESSION MATERIAL ESPE DENTAL PRODUCTS
K771326 08/02/1977 NIMETIC BONDING MATERIAL ESPE GMBH (US)
K771325 08/02/1977 NIMETIC ETCHING GEL ESPE GMBH (US)
K771328 08/03/1977 UVIOBOND ESPE GMBH (US)
K771327 08/02/1977 UVIOFIL ESPE GMBH (US)
K771299 08/04/1977 EMERGENCY OXYGEN RESUSCITATOR FRASER SWEATMAN, INC.
K771279 08/26/1977 HEAD FACILITATION VIBRATOR BK-5210 FRED SAMMONS, INC.
K771533 08/25/1977 DIGOXIN RIA KIT G.D. SEARLE AND CO.
K771180 08/03/1977 GAMMA GOUNTING SYS., AUTO, MODEL 1400 G.D. SEARLE AND CO.
K771239 08/02/1977 GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM G.D. SEARLE AND CO.
K771227 08/02/1977 AK-10 GAMBRO, INC.
K771151 08/04/1977 ARTIUS SYSTEM GENERAL ELECTRIC CO.
K771390 08/22/1977 HISTOCHEMICAL AFB DEMONSTRATION HARLECO
K771524 08/22/1977 HISTOCHEMICAL FERRIC IRON SET HARLECO
K771447 08/04/1977 PREGELLED DISP. EKG MONITORING ELECT- HAYES PRODUCTS, INC.
K771360 08/04/1977 ECG SCOPE MODEL 7833 HEWLETT-PACKARD CO.
K771194 08/03/1977 FETAL/MATERNAL ALRM MODULE - 21595A HEWLETT-PACKARD CO.
K771195 08/03/1977 FETAL/MATERNAL REPEATER - 21596A HEWLETT-PACKARD CO.
K771196 08/03/1977 MARKER GENERATOR MODULES - 21597A HEWLETT-PACKARD CO.
K771571 08/25/1977 MOBILE X-RAY SYS. MODEL 43820A HEWLETT-PACKARD CO.
K771572 08/30/1977 PATIENT MONITORS MODELS 78701A/78702A HEWLETT-PACKARD CO.
K771361 08/04/1977 PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A HEWLETT-PACKARD CO.
K771553 08/25/1977 SPIRAL SCALP ELECTRODE, 14499A HEWLETT-PACKARD CO.
K770966 08/18/1977 INTERNAL ECOLOGY MACHINE HOLISTIC EQUIPMENT, INC.
K771602 08/30/1977 MYERSONS SPEC. CROWN & BRIDGE RESIN HOWMEDICA CORP.
K771408 08/04/1977 WROUGHT (FORGED) VITALLIUM HOWMEDICA CORP.
K771259 08/22/1977 ALBUMIN TEST, HMA ALBUMIN TEST HYCEL, INC.
K771343 08/10/1977 LDH-INT TEST HYCEL, INC.
K771353 08/10/1977 PLATELET COUNTER & HEMATOCRIT ACCES. HYCEL, INC.
K771552 08/30/1977 LAS-R RHEUMATOID FACTOR TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771446 08/10/1977 TRANSPORTEO MODULE HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771453 08/22/1977 FLUID HANDLING DEVICE W/INPUT TUBING IMED CORP.
K770994 08/22/1977 FURNACE AUTOSAMPLER, MODEL 155 INSTRUMENTATION LABORATORY CO.
K771441 08/22/1977 MULTISTAT III CPK TEST INSTRUMENTATION LABORATORY CO.
K771443 08/22/1977 MULTISTAT III CREATININE TEST INSTRUMENTATION LABORATORY CO.
K771442 08/22/1977 MULTISTAT III UREA NITROGEN TEST INSTRUMENTATION LABORATORY CO.
K771374 08/04/1977 SCANNER TREND SYSTEM INSTRUMENTS FOR CARDIAC RESEARCH
K771372 08/04/1977 SYSTEM II IREX CORP.
K771510 08/16/1977 SERVO-PAK MOLEL 0030 ISOTHERMAL SYSTEMS, INC.
K771530 08/25/1977 TEMP. CROWN ACRYLIC RESIN J. PALMERO SALES CO., INC.
K771085 08/04/1977 DYNAZYME II ALKALINE PHOSPHATASE J.T. BAKER CHEMICAL CO.
K771084 08/04/1977 DYNAZYME II Y-GT J.T. BAKER CHEMICAL CO.
K771383 08/03/1977 ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP JOHNSON & JOHNSON PROFESSIONALS, INC.
K771396 08/03/1977 DISPENSER, MERCURY & TABLET/POWDER JOHNSON & JOHNSON PROFESSIONALS, INC.
K771519 08/26/1977 SPECIALIST ARM & LEG PROTECTOR JOHNSON & JOHNSON PROFESSIONALS, INC.
K770924 08/10/1977 GREEN RADIOPAQUE IN SURG. SPONGES KENDALL RESEARCH CENTER
K771242 08/03/1977 ANTISERA TO HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K771243 08/03/1977 ANTISERA TO HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K771549 08/25/1977 VERSATOME KERMATH MFG. CORP.
K771403 08/22/1977 EASE (MODIFICATION TO) L.D. CAULK CO.
K771400 08/22/1977 IMPREGNATED DENTAL FLOSS L.D. CAULK CO.
K771399 08/26/1977 LIP & CHEEK RETRACTOR L.D. CAULK CO.
K771402 08/26/1977 NUVA-COTE (MODIFICATION TO) L.D. CAULK CO.
K771404 08/03/1977 NUVA-FIL COMPOSITE RESTORATIVE (MODI.) L.D. CAULK CO.
K771401 08/22/1977 PROPHY PASTE L.D. CAULK CO.
K771398 08/26/1977 SHELL VENEER L.D. CAULK CO.
K771556 08/22/1977 EXR LITTON DENTAL PRODUCTS
K771557 08/19/1977 ULTRASON 990 LITTON DENTAL PRODUCTS
K770991 08/02/1977 SERUM GLUTAMIC PYRUVIC TRANSAMINASE MACOMB CHEMICAL CO.
K771312 08/03/1977 BLOOD UREA NITROGEN (BUN) REAGENT MALLINCKRODT CRITICAL CARE
K771219 08/04/1977 BRONCHO-CATH MALLINCKRODT CRITICAL CARE
K771310 08/03/1977 CALCIUM REAGENT MALLINCKRODT CRITICAL CARE
K771313 08/03/1977 CHOLESTEROL REAGENT MALLINCKRODT CRITICAL CARE
K771311 08/03/1977 GLUCOSE REAGENT (HEXOHINASE) MALLINCKRODT CRITICAL CARE
K771314 08/03/1977 GLUCOSE REAGENT (O-TOLUIDINE) MALLINCKRODT CRITICAL CARE
K771366 08/03/1977 INTERPLANTS MAURICES J. FAGAN, JR. B.S., D.D.S.
K771516 08/16/1977 CAPILLARY SAMPLE LINE MCGAW RESPIRATORY THERAPY
K771175 08/02/1977 RESUSCITATOR, MS30 MCKESSON CORP.
K771538 08/22/1977 LITHICRON MODEL 3-70C-B PULSE GENERATOR MEDCOR, INC.
K771121 08/03/1977 EMPTY ADMIXTURE CONTAINERS MEDI, INC.
K771231 08/16/1977 ARTEOIAL LINE KIT MEDICAL DISPOSABLES INTL., INC.
K771230 08/16/1977 PERCUTANEOUS INTRODUCER SHEATH SET MEDICAL DISPOSABLES INTL., INC.
K771463 08/26/1977 AERO PULSE ALTERNATING PRES. PUMP MEDLINE INDUSTRIES, INC.
K771395 08/19/1977 LAPAROTOMY SPONGES, STERILE MEDLINE INDUSTRIES, INC.
K771155 08/04/1977 ANTI-MITOCHONDRIAL MELOY LABORATORIES, INC.
K771033 08/04/1977 SMAC SYS., SUPPLEMENTAL PRODUCTS FOR MID TECH, INC.
K771559 08/25/1977 HEMA-TEK II SLIDE STAINER MILES LABORATORIES, INC.
K771308 08/22/1977 TISSUE-TEK III V.I.P. MILES LABORATORIES, INC.
K771220 08/04/1977 T3 RIA TEST SYSTEM MONOBIND
K771221 08/04/1977 T4 RIA TEST SYSTEM MONOBIND
K771222 08/04/1977 TSH RIA TEST SYSTEM MONOBIND
K771002 08/30/1977 ICE BAND NORCLIFF THAYER, INC.
K771387 08/22/1977 MONITORING LINES & FLUID ADMIN. NORTON PERFORMANCE PLASTICS CORP.
K771341 08/10/1977 SPINSEP-TBG NUCLEAR DIAGNOSTICS, INC.
K771304 08/04/1977 LIQUAEMIB SODIUM PRESERVATIVE, ETC. ORGANON, INC.
K771305 08/04/1977 LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. ORGANON, INC.
K771397 08/22/1977 MONOSTICON TEST ORGANON, INC.
K771527 08/16/1977 ACCU. CROWN COLD CURE PARKER LABORATORIES, INC.
K771359 08/22/1977 ALLERGIST PACK SYRINGES PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K771522 08/16/1977 FORCEPS, STYLE #849 PREMIER DENTAL PRODUCTS CO.
K771451 08/16/1977 SCUTABOND PREMIER DENTAL PRODUCTS CO.
K770580 08/04/1977 PEAK FLOW METER PROJECTS IN HEALTH
K771419 08/26/1977 CANNULA CLAMP QUINTON, INC.
K771424 08/26/1977 TUBE OCCLUDING FORCEPS QUINTON, INC.
K771347 08/03/1977 R&R ALSTON CARBIDE BURS RANSOM AND RANDOLPH
K771407 08/04/1977 LUNG VOLUME & PRESSURE MONITOR RESEARCH DEVELOPMENT CORP.
K771307 08/04/1977 BAIN BREATHING CIRCUIT RESPIRATORY CARE, INC.
K771367 08/02/1977 CHOLEDOCHOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771478 08/22/1977 INFUSION PUMP #6202 ROCHE MEDICAL ELECTRONICS, INC.
K771217 08/04/1977 ANESTHESIA RESPIRATOR RULE MEDICAL INSTRUMENTS, INC.
K771237 08/02/1977 NERVE STIMULATORS RULE MEDICAL INSTRUMENTS, INC.
K771225 08/03/1977 AP ISOTROL, #A 0140 SIGMA CHEMICAL CO.
K771379 08/03/1977 FETAL MONITORING SYS. MODEL FM3R SONICAID, INC.
K771493 08/16/1977 A.V. FISTULA NEEDLE SET (#341) SORENSEN RESEARCH
K771490 08/16/1977 A.V. FISTULA NEEDLE SET (#344) SORENSEN RESEARCH
K771492 08/16/1977 A.V. FISTULA NEEDLE SET (#351) SORENSEN RESEARCH
K771495 08/16/1977 A.V. FISTULA NEEDLE SET (#361) SORENSEN RESEARCH
K771491 08/16/1977 A.V. FISTULA NEEDLE SET (#364) SORENSEN RESEARCH
K771494 08/16/1977 A.V. FISTULA NEEDLE SET (354) SORENSEN RESEARCH
K770717 08/15/1977 IONTOPHORESIS SYSTEM MODULE, DM 500 SORENSEN RESEARCH
K771501 08/30/1977 ANEROID SPHYGMOMETER SWARTZ MEDICAL EQUIPMENT
K771502 08/30/1977 ANEROID SPHYGMOMETER SWARTZ MEDICAL EQUIPMENT
K771504 08/26/1977 STETHOSCOPE SWARTZ MEDICAL EQUIPMENT
K771505 08/26/1977 STETHOSCOPE SWARTZ MEDICAL EQUIPMENT
K771506 08/26/1977 STETHOSCOPE SWARTZ MEDICAL EQUIPMENT
K771581 08/26/1977 STETHOSCOPE, NURSESCOPE TYPE SWARTZ MEDICAL EQUIPMENT
K771434 08/22/1977 MULTI-CAVITY EQUILIBRIUM CELL TECHHNILAB INSTRUMENTS, INC.
K771384 08/22/1977 AUTOZYME IMMOBILIZED ENZYME COIL TECHNICON INSTRUMENTS CORP.
K771098 08/04/1977 BLOOD GROUPING SYS., BG-9 TECHNICON INSTRUMENTS CORP.
K771336 08/26/1977 SMA II TECHNICON INSTRUMENTS CORP.
K771486 08/22/1977 DUAL LAB-LITE LIGHT BOX TECHNILAB
K771458 08/26/1977 INFUSION ACCELERATOR TERUMO AMERICA, INC.
K771454 08/16/1977 MICRO SYRINGE & NEEDLE TERUMO AMERICA, INC.
K771444 08/16/1977 QUALICHECK TM THE LONDON CO.
K771263 08/03/1977 RADIOMHTER OSM-2 HEMOXIMETER THE LONDON CO.
K771156 08/02/1977 MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV THE PERKIN-ELMER CORP.
K770914 08/04/1977 INCUBATOR, PORTABLE, ACT-STAT THERMOLYNE CORP.
K771298 08/03/1977 6" L.L. SYSTEM TOSHIBA MEDICAL SYSTEMS
K771290 08/03/1977 CONTACT COMPOUNT SONOLAY. SAC-10A TOSHIBA MEDICAL SYSTEMS
K771292 08/16/1977 HIGH-SPEED SECTOR SCANNING SSL-52H TOSHIBA MEDICAL SYSTEMS
K771291 08/16/1977 IMAGE SCANNING TYPE SONOLAY. SAL-10A TOSHIBA MEDICAL SYSTEMS
K771296 08/03/1977 TUBE CONVEYOR MODEL DS-PB-4 TOSHIBA MEDICAL SYSTEMS
K771297 08/03/1977 TUBESTAND MODEL DS-TA-4 TOSHIBA MEDICAL SYSTEMS
K771293 08/03/1977 X-RAY DIAG. TABLE DT-KCS TOSHIBA MEDICAL SYSTEMS
K771295 08/03/1977 X-RAY GENERATOR MODEL KX0-825 TOSHIBA MEDICAL SYSTEMS
K771294 08/03/1977 X-RAY GENERATOR MODEL KXO-15 TOSHIBA MEDICAL SYSTEMS
K771348 08/02/1977 ECONOWRAP PAPER C.S.R. WRAP TOWER PRODUCTS, INC.
K771146 08/26/1977 STEOILITY TESTING VESSEL TOWER PRODUCTS, INC.
K771498 08/19/1977 CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET TRAVENOL LABORATORIES, S.A.
K771364 08/02/1977 LUBE JEL TRAVENOL LABORATORIES, S.A.
K771255 08/25/1977 CEBTRIA DIGOXIN RIA UNION CARBIDE CORP.
K771197 08/16/1977 NORTON ENDOTRACHEAL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K771302 08/02/1977 PFISTER-SCHWARTZ STONE RETRIEVER V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K771358 08/16/1977 CLINAC 20 VARIAN ASSOC., INC.
K771362 08/22/1977 FLU VEN 0150 VENOSPITAL, INC.
K771122 08/04/1977 VERI/CTGS MODEL 850 VERITE SCIENTIFIC, INC.
K771518 08/16/1977 INSPIRATORY FORCE ADAPTOR VITAL FLOW PRODUCTS CORP.
K771392 08/16/1977 ACCU-TRODE (DISP. ECG ELECTRODE) WARNER/CHILCOTT
K771481 08/19/1977 TONGUE BLADE HOLDER WELCH ALLYN, INC.
K770720 08/04/1977 TUBING PACK, EXTRACORPOREAL, H-3000 WILLIAM HARVEY LIFE PRODUCTS CORP.
K771596 08/26/1977 WILL-CERAM W-3 WILLIAMS GOLD REFINING CO., INC.
K770693 08/03/1977 X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC XONICS MEDICAL SYSTEMS, INC.


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