510(k) K991920

DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING by Dermaphylyx, Inc. — Product Code KMF

K991920 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1999
Date Received
June 7, 1999
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