510(k) K980382

NON-WOVEN COMPRESS by Convatec, A Division of E.R. Squibb & Sons — Product Code KMF

K980382 is an FDA 510(k) premarket notification submitted by Convatec, A Division of E.R. Squibb & Sons for the device "NON-WOVEN COMPRESS". The FDA issued a decision of SN on March 9, 1998. 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
SN ()
Decision Date
March 9, 1998
Date Received
February 2, 1998
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