Cleared Traditional

KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE

K131384 · Kericure, Inc. · General & Plastic Surgery

Aug 2014

Decision

450d

Days

Class 1

Risk

About This 510(k) Submission

K131384 is an FDA 510(k) clearance for the KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Kericure, Inc. (Apollo Beach, US). The FDA issued a Cleared decision on August 7, 2014, 450 days after receiving the submission on May 14, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K131384 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2013
Decision Date	August 07, 2014
Days to Decision	450 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF