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FJG — Dialyzer, Parallel Flow Class II

FDA Device Classification

Classification Details

Product Code
FJG
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K933681cobe renal careGAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSSeptember 7, 1994
K933680cobe renal careGAMBRO LUNDIA PRO 200 DIALYZERAugust 26, 1994
K920693national medical care, medical products divDEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9September 21, 1992
K915504c.g.h. medicalGAMBRO LUNDIA ALPHA HEMODIALYZERSMarch 6, 1992
K901368gambro-hospalHEMOSPAL KITS A1, A2D, AO, & A1DAugust 2, 1990
K902203akcess medical productsTENCKHOFF PERITONEAL DIALYSIS KITAugust 1, 1990
K862840gambroGAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NSeptember 29, 1986
K853406gambroGAMBRO LUNDIA PRO 3 & 5 DIALYZERJanuary 8, 1986
K820694cobe laboratoriesCOBE PPD 1.3L, #18-520-009March 31, 1982
K812336cobe laboratoriesCOBE PPD 1.9August 31, 1981
K811439extracorporeal medical specialitiesEXP 200 PARALLEL PLATE DIALYZERJune 12, 1981
K811440extracorporeal medical specialitiesEXP 600 PARALLEL PLATE DIALYZERJune 12, 1981
K810066cobe laboratoriesCOBE PPD .8June 9, 1981
K810837cyberexCYBER 80 HEMODIALYZERMay 5, 1981
K802478cyberexCYBER 120 HEMODIALYZERMarch 20, 1981
K803068nikkiso coNIKKISO ND-14 PARALLEL FLOW DIALYZERMarch 4, 1981
K802364extracorporeal medical specialitiesEXTRACORPOREAL'S EXP 400 PARALLEL PLATEJanuary 29, 1981
K802389gambroGAMBRO LUNDIA PLATE DISP. DIALYZERDecember 22, 1980
K801633bellco artifidial organ specTHE BRAVO NEW PARALLEL FLOW DIALYZERDecember 18, 1980
K801451medicalISONEPHROS-PEDIATRIC, STANDARD, OPTIMUMSeptember 26, 1980