EXE · Class I · 21 CFR 876.5900

FDA Product Code EXE: Protector, Ostomy

Leading manufacturers include Rudolfo T. Sanchez, Howmedica Corp. and Convatec, A Division of E.R. Squibb & Sons.

3
Total
3
Cleared
106d
Avg days
1977
Since

FDA 510(k) Cleared Protector, Ostomy Devices (Product Code EXE)

3 devices
1–3 of 3
Cleared Mar 06, 1991
CONVATEC ABSORBENT BANDAGE
K904233
Convatec, A Division of E.R. Squibb & Sons
Gastroenterology & Urology · 182d
Cleared Jul 15, 1977
UNITED SKIN BARRIER
K770982
Howmedica Corp.
Gastroenterology & Urology · 45d
Cleared Jan 26, 1977
STOMA SHIELD ADAPTER
K760927
Rudolfo T. Sanchez
Gastroenterology & Urology · 90d

About Product Code EXE - Regulatory Context