Winn Hirsch & Assoc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K880309TYPE 316L STAINLESS STEEL WIREFebruary 29, 1988
K864375TYPE 316L COTTER WIREMay 20, 1987
K832213GAUZE CONVERSION CLASS II STERILEJuly 26, 1983
K832214GAUZE CONVERSION CLASS I-NON-STERILEJuly 26, 1983
K830511ZANLEX, ZAN-TEX & ZANDEXMarch 17, 1983
K812391NEUROSPONGESNovember 24, 1981
K812390NEUROSPONGE PADDIENovember 24, 1981
K800195COTTON UNDER CAST PADDINGFebruary 11, 1980
K761155CELLULOSE EYE STICKDecember 16, 1976
K760513ELECTRODE, TEMPORARY MYOCARDIALOctober 15, 1976
K760365BLANKET, BURNAugust 11, 1976