FDA 510(k) Decisions During August, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K790848 08/10/1979 A-GENT QUANTICHROM T4 11A ABBOTT LABORATORIES
K782049 08/28/1979 BIOASSAY SYSTEM, MS-2 SERUM ABBOTT LABORATORIES
K790976 08/16/1979 RUBAZYME ABBOTT LABORATORIES
K791243 08/03/1979 LUBRICATING JELLY ABCO DEALERS, INC.
K791332 08/03/1979 UNIVERSAL FOLEY CATHETER TRAY ABCO DEALERS, INC.
K791133 08/28/1979 ABCOR CARIES DETECTOR MONITOR ABCOR, INC.
K791466 08/16/1979 ACE EXTERNAL BONE CLAMP PART #S11 ACE ORTHOPEDIC MANUFACTURING CO.
K791369 08/28/1979 AIRSTRIP THEATRE WARD DRESSING ACME UNITED CORP.
K791400 08/16/1979 GASTRIC LAVAGE KIT-DISPOSABLE ACUMED INSTRUMENTS CORP.
K791443 08/28/1979 TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE AIRLIFE, INC.
K791445 08/28/1979 TWO-PIECE IPPB MANIFOLD MACHINES AIRLIFE, INC.
K791444 08/28/1979 UNIVERSAL TWO-PIECE MACHINES AIRLIFE, INC.
K791333 08/10/1979 BOWLES STETHOSCOPE AMDIA MEDICAL PRODUCTS
K791336 08/03/1979 BUCKS NEUROLOGICAL HAMMER AMDIA MEDICAL PRODUCTS
K791338 08/10/1979 DUAL HEAD STETHOSCOPE AMDIA MEDICAL PRODUCTS
K791334 08/10/1979 MULTISCOPE AMDIA MEDICAL PRODUCTS
K791335 08/10/1979 NURSESCOPE AMDIA MEDICAL PRODUCTS
K791337 08/03/1979 TAYLOR NEUROLOGICAL HAMMER AMDIA MEDICAL PRODUCTS
K791412 08/16/1979 DISPOSABLE INSTRUMENT TRAY PAD ANAGO, INC.
K791222 08/22/1979 API 20E REAGENT QC ANALYTICAL PRODUCTS, INC.
K791147 08/03/1979 ARCO PROGAMMABLE PACEMAKER SYSTEM ARCO MEDICAL PRODUCTS CO.
K791499 08/28/1979 RAY-BAN SUN GLASSES BAUSCH & LOMB, INC.
K791428 08/22/1979 GLUCOHEMOGLOBIN CONTROL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K791290 08/03/1979 BECKMAN B-4 TEB BUFFER KIT BECKMAN INSTRUMENTS, INC.
K791141 08/10/1979 BILIRUBIN CALIBRATOR CONTROL BECKMAN INSTRUMENTS, INC.
K791341 08/16/1979 HUMAN ALPHA, ACID GLYCOPROTEIN BECKMAN INSTRUMENTS, INC.
K791340 08/16/1979 HUMAN ALPHA2 MACROGLOBULIN BECKMAN INSTRUMENTS, INC.
K791339 08/16/1979 HUMAN CERULOPLASMIN BECKMAN INSTRUMENTS, INC.
K790960 08/10/1979 QUANTIMUNE T-3 FIA BIO-RAD
K791007 08/03/1979 STAT DIFF STAIN BIOSCIENTIFIC
K790694 08/10/1979 BRITT LENS COMPUTER BRITT CORP., INC.
K791312 08/16/1979 CATALOG #4-2520 CHLORIDOMETER CHLORIDE BUCHLER INSTRUMENTS, INC.
K790855 08/03/1979 SURGICAL DRAPE CLIP #201 C. INTL.
K791235 08/16/1979 CADWELL 7000 ELECTROMYOGRAPH MACHINE CADWELL LABORATORIES, INC.
K791118 08/03/1979 HLA CONTROL SERA CALBIOCHEM-BEHRING CORP.
K791117 08/03/1979 RABBIT COMPLEMENT CALBIOCHEM-BEHRING CORP.
K791237 08/28/1979 PYROLITE CARBON ENDOSSEOUS DENTAL IMPL CARBOMEDICS, INC.
K791277 08/22/1979 MODEL 6500 EXTRACTION IRRIGATION SYS CAVITRON CORP.
K791296 08/03/1979 CHEMETRICS ANALYZER II CHEMETRICS CORP.
K791005 08/10/1979 CHEMODENT CERAMIC METAL CHEMODENT DENTAL LABORATORY
K791101 08/28/1979 DISPOSABLE PERFORATORS, JACOBS, HUDSON CODMAN & SHURTLEFF, INC.
K790920 08/03/1979 INTRACRANIAL PRESSURE MONITORING CODMAN & SHURTLEFF, INC.
K791230 08/16/1979 ELECTROSURGICAL GENERATOR (TIM) CONCEPT, INC.
K791468 08/22/1979 RESUSCI-BAG-VALVE CONCEPT, INC.
K791211 08/03/1979 BINDAFIX CONPHAR, INC.
K791245 08/03/1979 CONPHAR EXTERNAL CATHETER CONPHAR, INC.
K791257 08/03/1979 CONPHAR FEEDING TUBE-STERILE CONPHAR, INC.
K791270 08/03/1979 CONPHAR LEG BAG CONPHAR, INC.
K791251 08/03/1979 CONPHAR LEG BAG-STERILE CONPHAR, INC.
K791264 08/03/1979 CONPHAR NELATON CATHETER-STERILE CONPHAR, INC.
K791268 08/03/1979 CONPHAR RECTAL TUBE-STERILE CONPHAR, INC.
K791254 08/03/1979 CONPHAR SILICONE DRAINS-STERILE CONPHAR, INC.
K791269 08/03/1979 CONPHAR STOMACH TUBE-STERILE CONPHAR, INC.
K791250 08/03/1979 CONPHAR STOMACH TUBE-STERILE-X-RAY CONPHAR, INC.
K791262 08/03/1979 CONPHAR URINARY DRAINAGE BAG 2000ML CONPHAR, INC.
K791256 08/03/1979 SECUTEX SURGICAL BINDER CONPHAR, INC.
K791370 08/03/1979 SILICONE SURGICAL VESSEL LOOPS CONPHAR, INC.
K791096 08/03/1979 RADIOIMMUNOASSAY TEST SYSTEM CORNING MEDICAL & SCIENTIFIC
K791306 08/03/1979 ELLIK EVACUATOR DAVOL, INC.
K791424 08/28/1979 DCG-VII ELECTROCARDIOSCANNER DEL MAR AVIONICS
K790589 08/10/1979 DENTURE-TIGHT DEN-MAT CORP.
K791351 08/03/1979 CEMENT SPACERS DEPUY, INC.
K790774 08/03/1979 LODA WRIST PROSTHESIS DEPUY, INC.
K791167 08/03/1979 DEXIDE DISPOSABLE PREP PAD DEXIDE, INC.
K791498 08/28/1979 ADAPTER-Y TYPE/CORONARY PERFUSION DLP, INC.
K791302 08/16/1979 MANUAL MICRO ELISA READER #2-530 DYNATECH LABORATORIES, INC.
K791052 08/03/1979 ENDOSCOPIC INSTRUMENT EDER INSTRUMENT CO, INC.
K791299 08/16/1979 CPK ISOENZYME CONTROL ELECTROPHORESIS CORP. OF AMERICA
K791008 08/03/1979 ECA (SPECIAL) HEME BUFFER ELECTROPHORESIS CORP. OF AMERICA
K791300 08/16/1979 LDH ISOENZYME CONTROL ELECTROPHORESIS CORP. OF AMERICA
K791294 08/16/1979 SPIROCAL EQUILIBRATED BIO SYSTEMS, INC.
K791200 08/10/1979 PRE-DENT FICHTE, GRAVES, AND HUNT
K791346 08/03/1979 DISPOSABLE BEDPAN GENERAL CLINICAL PLASTICS CORP.
K791345 08/03/1979 MEDICINE CUP GENERAL CLINICAL PLASTICS CORP.
K790321 08/01/1979 DATASON DB GENERAL ELECTRIC CO.
K791213 08/10/1979 GLUCOSE (GDH) REAGENT GILFORD DIAGNOSTICS
K790807 08/03/1979 METALIT HARRY J. BOSWORTH CO.
K790806 08/03/1979 PORCELIT HARRY J. BOSWORTH CO.
K791144 08/03/1979 BUFFERIZER HELENA LABORATORIES
K791315 08/16/1979 SPECTRO-SUR SET HELENA LABORATORIES
K791288 08/03/1979 YELLOW ALERT SYSTEM HEMOY, INC.
K791487 08/28/1979 MODEL 78520A ARRHYTHMIA MONITORING SYS HEWLETT-PACKARD CO.
K790842 08/03/1979 SUBCUTANEOUS TISSUE EXPANDER HEYER SCHULTE CORP.
K791075 08/03/1979 H-H SLOTTED CATHETER-RESERVOIR HOLTER-HAUSNER INTL.
K791076 08/03/1979 H-H SLOTTED VENTRICULAR CATHETER HOLTER-HAUSNER INTL.
K791448 08/07/1979 HEMODIALYZERS RP-510 AND RP-514 HOSPAL MEDICAL CORP.
K791469 08/28/1979 MANIFOLD/NEBULIZER BREATHING PRODUCTS HOSPITAK, INC.
K791350 08/03/1979 POPE AMBULATORY HALO VEST HOSPITAL PRODUCTS CO.
K781923 08/03/1979 NON-RETENTION ENEMA SYSTEM HUDSON KENDALE ASSOC., INC.
K791386 08/16/1979 ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM IMMUNO-MYCOLOGICS, INC.
K791390 08/16/1979 ANTI-BLASTOMYCES SERUM #CF10027X IMMUNO-MYCOLOGICS, INC.
K791388 08/16/1979 ANTI-COCCIDIOIDES SERUM #CF10028X IMMUNO-MYCOLOGICS, INC.
K791395 08/16/1979 ANTI-HISTOPLASMA SERUM #CF10025X IMMUNO-MYCOLOGICS, INC.
K791392 08/16/1979 ANTI-HISTOPLASMA SERUM #CF10026X IMMUNO-MYCOLOGICS, INC.
K791387 08/16/1979 ASPERGILLUS MYCELIAL ANTIGEN #CF10024X IMMUNO-MYCOLOGICS, INC.
K791383 08/16/1979 CANDIDA IMMUNODIFFUSION KIT #CA1001 IMMUNO-MYCOLOGICS, INC.
K791381 08/16/1979 COCCIDIODES (COCCI) IMMUNO-MYCOLOGICS, INC.
K791389 08/16/1979 COCCIDIOIDES ANTIGEN #CF10023X IMMUNO-MYCOLOGICS, INC.
K791382 08/16/1979 CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION IMMUNO-MYCOLOGICS, INC.
K791384 08/16/1979 FUNGAL IMMUNODIFFUSION KIT #ID1001 IMMUNO-MYCOLOGICS, INC.
K791394 08/16/1979 HISTOPLASMA MYCELIAL #CF10020X IMMUNO-MYCOLOGICS, INC.
K791393 08/16/1979 HISTOPLASMA YEAST ANTI #CF10021X IMMUNO-MYCOLOGICS, INC.
K791385 08/16/1979 NEGATIVE CONTROL SERUM FOR CF RO ID IMMUNO-MYCOLOGICS, INC.
K791426 08/28/1979 PERITONEAL PAC INTERMED, INC.
K791518 08/22/1979 BIGGY AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K791517 08/22/1979 COLUMBIA BLOOD AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K791398 08/22/1979 CULTURE MEDIA FOR INSOLATION NEISSERIA ISLE MEDIA AND STERILE PRODUCTS, INC.
K791520 08/22/1979 EMB AGAR (EOSIN METHYLENE BLUE AGAR) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791481 08/22/1979 LAURYL TRYPTOSE BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791519 08/22/1979 LEVINE EMB AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K791482 08/22/1979 MACCONKEY MEDIA ISLE MEDIA AND STERILE PRODUCTS, INC.
K791470 08/22/1979 MODIFIED THAYER-MARTIN MEDIUM ISLE MEDIA AND STERILE PRODUCTS, INC.
K791485 08/22/1979 MUELLER HINTON AGARS ISLE MEDIA AND STERILE PRODUCTS, INC.
K791472 08/22/1979 PHENYLETHANOL AGAG (PEA) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791484 08/22/1979 SELENITE BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791471 08/22/1979 SELENITE CYSTINE BROTH ISLE MEDIA AND STERILE PRODUCTS, INC.
K791480 08/22/1979 SS AGAR (SALMONELLA SHIGELLA AGAR) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791483 08/22/1979 THAYER-MARTIN MEDIUM ISLE MEDIA AND STERILE PRODUCTS, INC.
K791514 08/22/1979 TRANSPORT MEDIUM STUART ISLE MEDIA AND STERILE PRODUCTS, INC.
K791515 08/22/1979 TRANSPORT MEDIUM STUART W/ CHARCOAL ISLE MEDIA AND STERILE PRODUCTS, INC.
K791473 08/22/1979 TRIPLE SUGAR IRON AGAR (TSI AGAR) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791516 08/22/1979 TRYPTIC SOY AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K790935 08/03/1979 DELTON* PIT AND FISSURE SEALENT JOHNSON & JOHNSON PROFESSIONALS, INC.
K791423 08/10/1979 "TOILET TRAINER FOR HANDICAPPED CHILD" KAYE PRODUCTS, INC.
K790720 08/16/1979 ANTISERA TO RABBIT IMMUNOGLOBULIN KENT LABORATORIES, INC.
K790710 08/03/1979 ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN KENT LABORATORIES, INC.
K790716 08/03/1979 ANTISERUM TO HUMAN C-REACTIVE PROTEINS KENT LABORATORIES, INC.
K790714 08/16/1979 ANTISERUM TO HUMAN CERULOPLASMIN KENT LABORATORIES, INC.
K790715 08/16/1979 ANTISERUM TO HUMAN FC KENT LABORATORIES, INC.
K790708 08/22/1979 ANTISERUM TO HUMAN IG G FC FRAGMENTS KENT LABORATORIES, INC.
K790712 08/16/1979 ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI KENT LABORATORIES, INC.
K790709 08/16/1979 ANTISERUM TO RABBIT IMMUNOGLOBULIN KENT LABORATORIES, INC.
K791207 08/28/1979 APOLLO HEART RATE INDICATOR KEY TRONIC CORP.
K791331 08/03/1979 THE TUCKER-SACH FOOT AND TUCKER-SYME FT KISWOOD MANUFACTURING, INC.
K791406 08/10/1979 CAM-10 CHEST SHELL LIFECARE SERVICES, INC.
K791297 08/10/1979 PRISMA LKB INSTRUMENTS, INC.
K791224 08/10/1979 MALIBU LABS MODEL 800 "FINGER TIP CONT" MALIBU LABORATORIES
K791097 08/03/1979 CEPTORTRODE WITH CEPTOR HESIVE MED GENERAL
K791095 08/10/1979 LITHICRON MODEL 0401, PACEMAKER MEDCOR, INC.
K791363 08/03/1979 "KWIK-AWA" VEST MEDICAL SPECIALTIES, INC.
K791287 08/16/1979 MEDICOR QUALITY CONTROL BUFFER MEDICOR USA LTD.
K791396 08/16/1979 MEDI-TRAK PORTABLE TRACTION DEVICE MEDICORP, INC.
K791325 08/16/1979 AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K791324 08/28/1979 MICROMEDIC APS2 MICROMEDIC SYSTEMS
K791313 08/16/1979 ARS, CHEMISTRY MID TECH, INC.
K791435 08/16/1979 AMES TDA/TOBRAMYCIN MILES LABORATORIES, INC.
K791175 08/10/1979 ANALYZER, SODIUM/POTASSIUM NOVA BIOMEDICAL CORP.
K791152 08/03/1979 TCO2M MODEL 818 NOVAMETRIX MEDICAL SYSTEMS, INC.
K790218 08/10/1979 BIPOLAR LEAD ADAPTOR, MODEL BA-415 PACESETTER SYSTEMS
K790428 08/10/1979 MDL-201A & T DL-201A PULSE GENERATOR PACESETTER SYSTEMS
K790141 08/10/1979 PULSE GENERATOR, R WAVE DEMAND PACESETTER SYSTEMS
K791307 08/03/1979 UNIPOR BREATHING CIRCUIT FILTER PALL BIOMEDICAL PRODUCTS CO.
K790909 08/03/1979 OPHTHALMIC DRESSING TRAY PENT-CAL, INC.
K791153 08/03/1979 ACTA-SCANNER 0220FS PFIZER, INC.
K791163 08/03/1979 PFIZER 0200FS LOCALLZER PFIZER, INC.
K791565 08/28/1979 PARAPODIUM PHYSICO-MEDICAL SYSTEMS CORP.
K790637 08/28/1979 COMPUTERIZED ELECTRO-OCULOGRAPH POTOMAC MEDICAL SYSTEM
K791212 08/10/1979 VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG PRECISION MEDICAL INSTRUMENTS, INC.
K791274 08/03/1979 "RELY TAMPON" PROCTER & GAMBLE MFG. CO.
K791115 08/03/1979 GOAR ANTI-HUMAN LAMBODA CHAIN PROTOS LABORATORIES
K791364 08/03/1979 QUINTON MODEL 630 AND 636 ECG DATA CART QUINTON, INC.
K790949 08/16/1979 GALVANIC UNIT RAMI INTERNATIONAL CORP.
K791420 08/28/1979 MINIGRAPH MG-I ELECTROCARDIOGRAPH RENESCO INTERNATIONAL, INC.
K791421 08/28/1979 MINISCOPE MS-2B ELECTROCARDIOSCOPE RENESCO INTERNATIONAL, INC.
K791053 08/16/1979 THE DENVER SPLINT RONALD D. SHIPPERT, M.D.
K791199 08/03/1979 ANESTHESIA OXYGEN ANALYZER MODEL 101 RULE MEDICAL INSTRUMENTS, INC.
K791295 08/10/1979 BAYLOR VISUAL FIELDS PROGRAMMER SCHIFF HARDING WAITE
K790950 08/03/1979 S/A 7800 BIRTH SUPPORT CHAIR SCHLOSSER ALBERTI CO.
K790951 08/03/1979 SA/7860 FETAL HEART MONITOR (DOPPLER) SCHLOSSER ALBERTI CO.
K791078 08/10/1979 ANTERIOR/POSTERIOR RESTORATIVE, BOND SCIENTIFIC PHARMACEUTICALS, INC.
K791132 08/10/1979 SCI-PHARM ORTHODONTIC ADHESIVE SCIENTIFIC PHARMACEUTICALS, INC.
K791067 08/10/1979 SCI-PHARM PAINT-ON RESTORATIVE SCIENTIFIC PHARMACEUTICALS, INC.
K791327 08/22/1979 ARGYLE TAUSSIG CULTURE CATHETER SHERWOOD MEDICAL CO.
K791225 08/10/1979 BJORK-SHILEY AORTIC GRAFT VALVE PROSTH SHILEY, INC.
K791203 08/10/1979 MODEL SE-1 EYEGLASS HEARING AID STARKEY LABORATORIES, INC.
K791227 08/03/1979 PARA-7 STRECK LABORATORIES, INC.
K791228 08/03/1979 PARA-8 STRECK LABORATORIES, INC.
K791226 08/03/1979 PLATELET-CHEX PLUS STRECK LABORATORIES, INC.
K791408 08/10/1979 MAINSTREAM ELEVATING WHEEL CHAIR SUMMIT SERVICES, INC.
K791500 08/28/1979 BARRIER *450* TAPE STRIP SURGIKOS, INC.
K791438 08/28/1979 BARRIER* C-ARM DRAPE SURGIKOS, INC.
K791439 08/28/1979 BARRIER* OVERHEAD TABLE DRAPE SURGIKOS, INC.
K791440 08/28/1979 BARRIER* X-RAY CASSETTE DRAPE SURGIKOS, INC.
K791486 08/28/1979 FABRIC 450* TOWEL DRAPE SURGIKOS, INC.
K791619 08/28/1979 "DYNAMIC HIP SCREW" SYNTHES (USA)
K791019 08/03/1979 MCSPADDEN CONDENSOR TECHDENT, INC.
K791361 08/16/1979 T3 UPTAKE RADIOIMMUNOASSAY KIT TECHNIA DIAGNOSTICS LTD.
K791110 08/03/1979 KINETIC DETERMINATION OF UV GLUCOSE THE DOW CHEMICAL CO.
K791074 08/22/1979 MODEL MHS-20, ATOMIC ABSORPTION ACCESS THE PERKIN-ELMER CORP.
K791220 08/03/1979 FLOWMETER, BACK PRESSURE COMPENSATED, TIMETER INSTRUMENT CORP.
K791430 08/28/1979 MINIPRIME HYPOTHERMIC HEAT EXCHANGER TRAVENOL LABORATORIES, S.A.
K791106 08/10/1979 STERILE, DISPOSABLE CENTRIFUGE BOWL TRAVENOL LABORATORIES, S.A.
K791180 08/10/1979 CENTRIFICHEM SYSTEM 500 UNION CARBIDE CORP.
K791177 08/10/1979 DISPIRO UTAH MEDICAL PRODUCTS, INC.
K790893 08/28/1979 STAT VARIAN ASSOC., INC.
K791308 08/03/1979 ULDALL SUBCLAVIAN CANNULA SC-100 VAS-CATH OF CANADA LTD.
K791355 08/10/1979 VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT VENTREX LABORATORIES, INC.
K791187 08/22/1979 MODEL 810 VERI/TGS VERITE
K790878 08/03/1979 SCREENING AUDIOMETER, HIGH FREQUENCY VICON INSTRUMENT CO.
K791503 08/16/1979 VITALOGRAPH FUNCTION ANALYZER VITALOGRAPH LTD.
K791407 08/22/1979 WOMED NICRO-CRAFT POWER SYSTEM XOMED, INC.
K791209 08/03/1979 IVAC 819 ELECTRONIC THERMOMETER Y
K791208 08/03/1979 IVAC 833 ELECTRONIC THERMOMETER Y


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