510(k) K131384

KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE by Kericure, Inc. — Product Code KMF

K131384 is an FDA 510(k) premarket notification submitted by Kericure, Inc. for the device "KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Kericure, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
May 14, 2013
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