510(k) K904233

CONVATEC ABSORBENT BANDAGE by Convatec, A Division of E.R. Squibb & Sons — Product Code EXE

K904233 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "CONVATEC ABSORBENT BANDAGE". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code EXE (Protector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Convatec, A Division of E.R. Squibb & Sons has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1991
Date Received
September 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type