510(k) K002338

LIQUIDERM LIQUID ADHESIVE BANDAGE by Closure Medical Corp. — Product Code KMF

K002338 is an FDA 510(k) premarket notification submitted by Closure Medical Corp. for the device "LIQUIDERM LIQUID ADHESIVE BANDAGE". The FDA issued a decision of Substantially Equivalent on January 29, 2001. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Closure Medical Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2001
Date Received
August 1, 2000
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