FHS — Dialyzer, Single Coil Class II

FDA Device Classification

Classification Details

Product Code
FHS
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
K812811erikaMICROCOIL 80 DIALYZERDecember 3, 1981
K811974erikaMICROCOIL 150 DIALYZERSeptember 16, 1981
K801634bellco artifidial organ specTHE VITA 2 DISPOSABLE DIALYZERDecember 17, 1980
K800723erikaMICRO-COIL 100 COIL DIALYZERMay 14, 1980
K800174gambroGAMBRO LUNDIA COIL DIALYZERFebruary 13, 1980
K790223travenol laboratoriesDIALYZER, CD-800 COILMarch 26, 1979
K781102gambroDIALYZER, DISP., COIL, LUNDIAOctober 17, 1978
K771349erikaMODIFICATION TO KIDNEY DIALYZERAugust 2, 1977
K770735travenol laboratoriesDIALYZER, COIL, CD, LSA, 5M1765May 10, 1977
K761358bentley laboratoriesCOIL DIALYZER MODEL ALT 140January 10, 1977
K760702erikaERI-FLO 900 DIALYZERNovember 19, 1976
K760374erikaDIALYZER (MODEL 1850)October 27, 1976