FDA 510(k) Decisions During July, 1980  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K801566 07/21/1980 CYBREX PHENOBARBITAL ABBOTT LABORATORIES
K801565 07/21/1980 CYBREX PHENYTOIN ABBOTT LABORATORIES
K801567 07/21/1980 CYBREX THEOPHYLLINE ABBOTT LABORATORIES
K801515 07/08/1980 ABBY II PATIENT MONITOR OR VITAL SIGNS M ABBOTT MEDICAL ELECTRONICS CO.
K801430 07/08/1980 CONTROL SYRINGE ABCO DEALERS, INC.
K801406 07/28/1980 MARK III ULTRASONIC SCANNING SYSTEM ADVANCED TECHNOLOGY LABORATORIES, INC.
K801435 07/18/1980 ORGANON ARTERIAL BLOOD SAMPLER AKZONA, INC.
K801463 07/21/1980 OJ-1 ENDODONIC ROOT CANAL FILE HOLDER ALMORE INTL., INC.
K801113 07/28/1980 DILATOR, VESSEL, FOR PERC. CATHETER. ALVA MEDICAL, INC.
K801570 07/28/1980 SHIELD DISP. PATIENTS PONCHO GOWNS AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K801568 07/28/1980 SHIELD DISPOSABLE BLOOD PRESSURE CUFF AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K801569 07/28/1980 VAL-U-WRAP CSR WRAP AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K800496 07/21/1980 CYCLER W/5 OR 10 HR. FILL/DWELL TIMER AMERICAN MEDICAL PRODUCTS, INC.
K801413 07/08/1980 AMERLEX DIGOXIN RIA KIT AMERSHAM CORP.
K801437 07/14/1980 DISPENSING SEROLOGICAL PIPET AMT CORP.
K801373 07/14/1980 BECKMAN MODEL 42 SPECTROPHOTOMETER BECKMAN INSTRUMENTS, INC.
K801389 07/28/1980 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON BIB, INC.
K801366 07/28/1980 DISPOSABLE TEMPERATURE PROBE COVER BIB, INC.
K800596 07/21/1980 VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR BIB, INC.
K801345 07/08/1980 KAMPNER HINGED TOE PROSTHESIS BIOMEDICS
K801268 07/14/1980 HEMOGLOBIN CONTROL LEVELS BIOSCIENTIFIC
K801267 07/14/1980 RED BLOOD CELL COUNT & HEMATOCRIT CNTL BIOSCIENTIFIC
K801265 07/14/1980 WHITE BLOOD CELL COUNT CONTROL LEVELS BIOSCIENTIFIC
K801558 07/28/1980 ENTERIC FEEDING TUBE W/SEGM. FLEX. WT. BIOSEARCH MEDICAL PRODUCTS, INC.
K801498 07/28/1980 ENTRI NASOGASTRIC FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC.
K801198 07/21/1980 FOLATE RADIOASSAY KIT CALBIOCHEM-BEHRING CORP.
K801485 07/08/1980 SERIES 602 CKG RECORDER (MODIFIED) CARDIOKINETICS, INC.
K801643 07/28/1980 TRITON CHATTANOOGA GROUP, INC.
K801211 07/14/1980 COBE HEMOFLO BLOOD TUBING SETS COBE LABORATORIES, INC.
K801178 07/28/1980 COBE HF80, CAT. #18-580 COBE LABORATORIES, INC.
K801231 07/21/1980 EYE-VAC COBURN OPTICAL IND., INC.
K801336 07/28/1980 MODEL 900K PHOTOCOAGULATOR COHERENT MEDICAL DIVISION
K801031 07/28/1980 BLADE SEPTOSTOMY CATHETER COOK, INC.
K801411 07/21/1980 MAY ILLUMINATED/INFUSION PIC COOPER MEDICAL DEVICES CORP.
K801354 07/08/1980 BIONICS ARTERIAL/VENOUS FISTULA NEEDLE CORDIS CORP.
K801356 07/08/1980 BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET CORDIS CORP.
K801355 07/08/1980 BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR CORDIS CORP.
K801106 07/08/1980 MULTICOR (GAMMA) MODEL 336 & MODEL 337 CORDIS CORP.
K801380 07/08/1980 CROWN DELTA SILICONE IMPRESSION MATERIAL CROWN DELTA CORP.
K801291 07/08/1980 EC-4 PLETHYSMOGRAPH D. E. HOKANSON, INC.
K801587 07/21/1980 ASH BLUEPRINT ALGINATE IMPRESSION MATER. DENTSPLY INTL.
K801548 07/21/1980 PERF-LOCK IMPRESSION TRAY DENTSPLY INTL.
K801352 07/08/1980 HEMORRHOIDAL LIGATION INSTR. SYSTEM DEPUY, INC.
K801277 07/21/1980 GDC 934 DERINGER-NEY INC.
K801421 07/28/1980 TUBE HOLDER DEVON INDUSTRIES, INC.
K801473 07/28/1980 CINOXACIN 100 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K801286 07/08/1980 PORTA-NEB(R) 310 E.B.E. RESEARCH & MFG., INC.
K801300 07/08/1980 DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) E.I. DUPONT DE NEMOURS & CO., INC.
K801469 07/28/1980 BONN MICRO IRIS HOOK (NON-STERILE) #7613 EDWARD WECK, INC.
K801467 07/28/1980 DODICK LENS HOLDING FORCEPS EDWARD WECK, INC.
K801465 07/28/1980 GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE EDWARD WECK, INC.
K801466 07/28/1980 LEIGH MEASURING SCALE #7725 EDWARD WECK, INC.
K801470 07/14/1980 MICRO CLIP STERILIZING CASE #65199 EDWARD WECK, INC.
K801444 07/14/1980 SKIN STAPLE REMOVER #523770 EDWARD WECK, INC.
K801445 07/14/1980 SKIN STAPLER HANDLE 523700/CARTRIDGES EDWARD WECK, INC.
K801552 07/28/1980 MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR EDWARDS LABORATORIES
K800787 07/14/1980 ANTIBODY TO VARICELLA-ZOSTER VIRUS ELECTRO-NUCLEONICS LABORATORIES, INC.
K801061 07/21/1980 TOTAL PROTEIN TEST ENVIRONMENTAL CHEMICAL SPECIALTIES
K801439 07/21/1980 MODEL 5100 ELECTROCHEMICAL DETECTOR ENVIRONMENTAL SCIENCES ASSOC., INC.
K801344 07/21/1980 EXTRACORPOREALS' ALTERNATE MEMBRANE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K801429 07/28/1980 SUNSATION FASHION, INC.
K801381 07/28/1980 FITE FIXATION TOY FOR OCULAR EXAM FITE ENGINEERING CORP.
K800815 07/21/1980 ENTERAL & NASOGASTRIC SOL. ADMIN. SET G.D. SEARLE AND CO.
K801370 07/21/1980 GF-120-L DIALYZER GAMBRO, INC.
K801011 07/08/1980 AVL #980 ELECTROLYTE ANALYZER GAUNTLET TECHNOLOGY CORP.
K801378 07/14/1980 HIPP BUFFER(NON-BARBITAL), P/N GELMAN SCIENCES, INC.
K800925 07/21/1980 VERIFY S PROD. #34141 GENERAL DIAGNOSTICS
K801320 07/21/1980 SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 GENERAL ELECTRIC CO.
K801138 07/14/1980 MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. GICS PHARMACEUTICALS
K801449 07/21/1980 BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 HEALTH DIAGNOSTICS CORP.
K801318 07/14/1980 HELENA ULTRA SENSITIVE CPK REAGENT/DILUE HELENA LABORATORIES
K800850 07/21/1980 HIGH STOY SMALL PARTS SCANNER #SP-100B HIGHSTOY
K800553 07/21/1980 ULTRA IMAGER HONEYWELL, INC.
K801511 07/28/1980 NASO-GARD NASOGASTRIC TUBE HOLDER HOWMEDICA CORP.
K801471 07/28/1980 SUPER BANISH DEODORANT HOWMEDICA CORP.
K801359 07/28/1980 PRUITT VASCULAR SHUNT IDEAS FOR MEDICINE, INC.
K801513 07/28/1980 TISSUE PROCESSING SYSTEM INNOVATIVE MEDICAL SYSTEMS, INC.
K801350 07/14/1980 ACUVAC(TM) SUCTION RESERVOIR 400CC AND INNOVATIVE SURGICAL PRODUCTS INC.
K800405 07/21/1980 A-V MINI CLINIC INSTROMEDIX, INC.
K801038 07/08/1980 ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 INTERMEDICS, INC.
K801039 07/21/1980 ADAPTAID HELICAL COIL ADAPTER 365-14 INTERMEDICS, INC.
K801557 07/21/1980 ROLLS ROLLITE WHEELCHAIR INVACARE CORP.
K800749 07/28/1980 IPOCON 7 IPOS LUNEBURG
K801410 07/21/1980 HEMOHLOBIN A2 CONTROL-LYOPHILIZED ISOLAB, INC.
K801168 07/08/1980 COLLIMAX X-RAY COLLIMATOR # R-182 ITO X-RAY CORP.
K801273 07/28/1980 MAGILL CATHETER INTRO. FORCEPS J. SKLAR MFG. CO., INC.
K801362 07/21/1980 ALBUMIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801433 07/08/1980 HAPTOGLOBIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801432 07/08/1980 HEMOPEXIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801434 07/08/1980 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS J.T. BAKER CHEMICAL CO.
K801388 07/28/1980 OH-HARRIS JOHNSON & JOHNSON PROFESSIONALS, INC.
K801418 07/21/1980 KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT KEELER OPTICAL PRODUCTS LTD.
K801358 07/21/1980 NEW FREEDOM ANYDAY PANTILINERS KIMBERLY-CLARK CORP.
K800653 07/21/1980 SINVISION LINEAR ARRAY REAL TIME KT MEDICAL, INC.
K801592 07/21/1980 FIBER OPTIC HOSE LARES MANUFACTURING CO., INC.
K801591 07/21/1980 FIBER OPTIC ILLUMINATOR LARES MANUFACTURING CO., INC.
K801534 07/14/1980 LARES AIR PRESSURE GAUGE LARES MANUFACTURING CO., INC.
K801490 07/14/1980 DIGOXIN EIA KIT M.A. BIOPRODUCTS
K801620 07/21/1980 ASPIRATOR MARQUEST MEDICAL PRODUCTS, INC.
K801462 07/28/1980 SPOR-O-THERM MDT CORP., INC.
K801549 07/14/1980 MODEL R11 SINGLE CHANNEL CHART RECORDER MEDASONICS, INC.
K800768 07/08/1980 VASCULAB BI-DIRECTIONAL DOPPLER, #D10 MEDASONICS, INC.
K801495 07/21/1980 CARDIO-PULMONARY EXERCISE STRESS SYSTEM MEDICAL GRAPHICS CORP.
K801496 07/21/1980 PULMONARY LAB AUTOMATION SYSTEM MEDICAL GRAPHICS CORP.
K801457 07/14/1980 ACCU-CORE DISPOSABLE BIOPSY NEEDLE MEDLINE INDUSTRIES, INC.
K801368 07/21/1980 A2 IMAGE PROCESSING SYSTEM MEDTRONIC VASCULAR
K801384 07/08/1980 MYELOSTAT DORSAL CORD STIMULATOR, ETC. MEDTRONIC VASCULAR
K800816 07/08/1980 HIPPUR-ASE TUBES MICROCHEMICAL SPECIALITIES, CO.
K801269 07/08/1980 SERALYZER BLOOD UREA NITROGEN(BUN) MILES LABORATORIES, INC.
K801270 07/08/1980 TEST FOR KETONE IN URINE(ACETOACETIC AC MILES LABORATORIES, INC.
K801426 07/28/1980 TISSUE-TEK III MICROJECT DISP. BLADE SYS MILES LABORATORIES, INC.
K801427 07/28/1980 TISSUE-TEK III MINI-RAPID PROCESSOR MILES LABORATORIES, INC.
K800918 07/28/1980 MODIFIED FEEDING JEJUNOSTOMY TUBE MITCHELL V. KAMINSKI, JR., M.D.
K801544 07/14/1980 PORTA-FIB LPD NARCO BIO-SYSTEMS
K801482 07/21/1980 HYDRON ROOT CANAL FILLING MATERIAL NATIONAL PATENT DEVELOPMENT CORP.
K801483 07/21/1980 MARK IV SYRINGE NATIONAL PATENT DEVELOPMENT CORP.
K801484 07/21/1980 ROOT CANAL FILLING APPLICATOR NEEDLES NATIONAL PATENT DEVELOPMENT CORP.
K801506 07/28/1980 CERTIFIED BLOOD BANK SALINE NOBEL SCIENTIFIC INDUSTRIES, INC.
K801425 07/14/1980 RH CONTROL NORTH AMERICAN BIOLOGICALS, INC.
K801641 07/28/1980 OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT OHIO MEDICAL PRODUCTS
K801169 07/28/1980 OHIO FREE FLOW VACUUM REGULATOR OHIO MEDICAL PRODUCTS
K801236 07/08/1980 REIGNING EPOXY RESIN CEMENT OKI SHIKS USA LTD.
K801461 07/28/1980 THERMA-SHIELD OLYMPIC MEDICAL CORP.
K801452 07/14/1980 OROTRACHEAL INTUBATION ENDOSCOPE OLYMPUS CORP.
K801606 07/28/1980 RETREAT OMNITRONICS RESEARCH CORP.
K801385 07/21/1980 K1 POTASSIUM ACETATE ADDITIVE ORGANON TEKNIKA CORP.
K801440 07/21/1980 SORB 10 DIALYSATE INFUSATE C1 INFUSATE ORGANON TEKNIKA CORP.
K801448 07/21/1980 OTICON MODEL E17P EARETTE HEARING AID OTICON CORP.
K801239 07/14/1980 STERILE, DISP DOME, INDIVID. PKG. PACIFIC DOMES, INC.
K801460 07/28/1980 PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT PACIFIC HEMOSTASIS
K801446 07/28/1980 PFIZER PZ-CT SCANNER PFIZER MEDICAL SYSTEMS, INC.
K801408 07/28/1980 CINESCOPE III PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K800805 07/21/1980 LINEAR ARRAY SCANNER PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K801407 07/28/1980 SYNERVIEW MODEL 6545 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K801516 07/14/1980 PRE-DENT SYSTEM MODIFIED PRE-DENT SYSTEM
K801386 07/14/1980 PRE-DENT SYSTEM OR PRE-DENT II PRE-DENT SYSTEM
K801443 07/14/1980 P-S SUCTION RESERVOIR PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K801442 07/14/1980 P-S SURGICAL DRAIN PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K801317 07/21/1980 QUADRA WHEELCHAIR, QUADRA CHAIR, ETC. QUADRA WHEELCHAIRS, INC.
K801351 07/28/1980 EPILATOR, MODEL CP-16 R. A. FISCHER CO. CORP.
K801305 07/21/1980 HIPPURATE DISK REMEL CO.
K800803 07/08/1980 NITRATE SWAB-RAPID TEST REMEL CO.
K801556 07/28/1980 RIONET HEARING AID HB-66 RION ACOUSTIC INSTRUMENTS, INC.
K801299 07/14/1980 COBAS CK-NAC REAGENT ROCHE ANALYTICAL INSTRUMENTS, INC.
K801295 07/08/1980 COBAS REAGENT FOR A-AMYLASE ROCHE ANALYTICAL INSTRUMENTS, INC.
K801298 07/08/1980 COBAS REAGENT FOR TRIGLYCERIDES & COBAS ROCHE ANALYTICAL INSTRUMENTS, INC.
K801422 07/08/1980 SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. SANDARE CHEMICAL CO., INC.
K801177 07/08/1980 ASO QUANTUM, ANTISTREPTOLYSIN O TEST SCLAVO, INC.
K801522 07/28/1980 ARGYLE RIGID URINE MEASURING/COLL. DEV. SHERWOOD MEDICAL CO.
K801551 07/21/1980 ARGYLE SAF-T-MARK SUCTION CATHETER SHERWOOD MEDICAL CO.
K801070 07/21/1980 SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES SHERWOOD MEDICAL INDUSTRIES
K801375 07/14/1980 SHILEY CARDIOTOMY RESERVOIR W/FILTER SHILEY, INC.
K801489 07/14/1980 EZ ON SAFETY PONCHO SKIL-CARE CORP.
K801424 07/21/1980 ESTRIOL RIA KIT FOR USE WITH GAMMAFLO SQUIBB & SONS, INC.
K801523 07/14/1980 MODEL 379 WXYGEN CONCENTRATOR STANLEY AVIATION CORP.
K801458 07/28/1980 WINTER HEAD DRESSING STERIDYNE CORP.
K801095 07/21/1980 "THE SUN BOOTH" SUN BOOTHS LTD.
K801163 07/21/1980 SUNBURST, SUN SYSTEMS OR BC2 SUN RAY MFG., INC.
K801530 07/28/1980 COREFORM MOLDS SYBRON CORP.
K801475 07/08/1980 APPLICATION OF EMIT AED ASSAYS SYVA CO.
K801476 07/08/1980 APPLICATION OF EMIT THEOPHYLLINE ASSAY SYVA CO.
K801341 07/21/1980 TAN YEAR ROUND SUN BED TAN-YEAR ROUND, INC.
K801509 07/14/1980 HI-M-TEST FOR METHADONE TEST #2 TECHNAM, INC.
K801024 07/28/1980 ODOR MASKING AGENT IN BOUNDARY OBSTETRI. THE BUCKEYE CELLULOSE CORP.
K801526 07/21/1980 SURVEYOR I, RESPIRATORY COMPUTER SYSTEM THE DEVILBISS CO.
K800957 07/14/1980 DOUCHE UNIT-1500 ML DISP. CONTAINER THE HEALTHCARE GROUP LABORATORIES, INC.
K801531 07/21/1980 ARM SLING THE OWENBY CO.
K801626 07/28/1980 ARM SLING THE OWENBY CO.
K801627 07/28/1980 COVER, LIMB THE OWENBY CO.
K801532 07/28/1980 STOCKINETTE, STERILE TWO PLY W/PULL TABS THE OWENBY CO.
K801514 07/14/1980 TIMETER PRODUCED PURRITAN BENNETT O2 ADP TIMETER INSTRUMENT CORP.
K800627 07/14/1980 AMBULATORY INFUSION PUMP, CODE 2M9807 TRAVENOL LABORATORIES, S.A.
K801360 07/14/1980 CARDIOTOMY RESERVOIR WITH FILTER TRAVENOL LABORATORIES, S.A.
K801391 07/14/1980 DISC 120 TRANSPORTER TRAVENOL LABORATORIES, S.A.
K801020 07/08/1980 GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- TRAVENOL LABORATORIES, S.A.
K801409 07/14/1980 GAMMADAB B-HCG RADIOIMMUNOASSAY KIT TRAVENOL LABORATORIES, S.A.
K800624 07/14/1980 LOW-ACETATE HEMODIALYSIS BATH CONCENTR. TRAVENOL LABORATORIES, S.A.
K801625 07/28/1980 THERMOLATOR HEATING UNIT TRU-EZE MFG. CO., INC.
K801438 07/28/1980 CENTRIFICHEM SYSTEM MANAGER UNION CARBIDE CORP.
K801021 07/28/1980 URINEBAG UNOVEX OF DENMARK
K801335 07/08/1980 UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE WARNER-LAMBERT CO.
K801247 07/28/1980 CCD ENDOSCOPE AND ATTACHMENTS WELCH ALLYN, INC.
K801303 07/28/1980 MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST WESTERN LABORATORIES CORP.
K801342 07/08/1980 DISPOSABLE ARTICULATOR WILLIAMS GOLD REFINING CO., INC.
K801285 07/28/1980 YSI MODELS 23C & 23CM HDL & TOTAL CHOLES YELLOW SPRINGS INSTRUMENT CO., INC.
K801525 07/21/1980 ZEST ENDODONTIC STABILIZER ZEST ANCHORS, INC.
K801524 07/21/1980 ZEST PLANT ZEST ANCHORS, INC.


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