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General Medical Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K926269PROCEDURE KITAugust 27, 1993
K912975OPERAND LUBRICATING JELLYSeptember 27, 1991
K912132OPERAND LUBRICATING JELLYAugust 7, 1991
K903669GENESIS INSUFFLATING CATHETERSeptember 12, 1990
K900110OPERAND* LUBRICATING JELLYMay 2, 1990
K853635SUBDERM TMDecember 20, 1985
K844652C.A.S.E. CONTAINERDecember 12, 1984
K831320DRIONICJuly 19, 1983
K820689C.S.R. WRAPPERSApril 9, 1982
K820521STERILIZATION WRAPMarch 18, 1982
K802231AIR VIVA IIOctober 10, 1980
K772089LAPAROTOMY SPOGNENovember 11, 1977
K770583MEDI-PAK LEMON GLYCEOIN SWABSMay 26, 1977
K770488ISOLATION GOWNMay 23, 1977
K770476EXAM GOWNMay 6, 1977