510(k) K973429

BIODERM FOAM WOUND DRESSING by Bioderm, Inc. — Product Code KMF

K973429 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "BIODERM FOAM WOUND DRESSING". The FDA issued a decision of SN on December 1, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Bioderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 1, 1997
Date Received
September 10, 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