510(k) K050757

FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE by Chemence Medical, Inc. — Product Code KMF

K050757 is an FDA 510(k) premarket notification submitted by Chemence Medical, Inc. for the device "FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on February 23, 2006. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Chemence Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2006
Date Received
March 23, 2005
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