510(k) K972530

CONVATEC ODOR CONTROL WOUND DRESSING by Convatec, A Division of E.R. Squibb & Sons — Product Code KMF

K972530 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "CONVATEC ODOR CONTROL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. 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
October 1, 1997
Date Received
July 7, 1997
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