510(k) K954918

COMBIDERM ACD by Convatec, A Bristol-Myers Squibb Co. — Product Code KMF

K954918 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "COMBIDERM ACD". The FDA issued a decision of Substantially Equivalent on December 26, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1995
Date Received
October 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type