Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage

FDA 510(k) K131384 · Kericure, Inc.

Substantially Equivalent

510(k) numberK131384

Submission

Device name
Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage
Applicant
Kericure, Inc.
Apollo Beach, FL, US
Received
May 14, 2013
Decision date
August 7, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KMF – Bandage, Liquid
Device class
Class I (low risk)
Regulation
21 CFR 880.5090
Specialty
General Hospital

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Questions and answers

When was Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage cleared by the FDA?

Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage (K131384) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 450 days after the submission was received.

What is the product code of K131384?

The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.