Cleared Traditional

MARATHON NO STING LIQUID SKIN PROTECTANT

K133443 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery
Jul 2014
Decision
240d
Days
Class 1
Risk

About This 510(k) Submission

K133443 is an FDA 510(k) clearance for the MARATHON NO STING LIQUID SKIN PROTECTANT, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on July 10, 2014, 240 days after receiving the submission on November 12, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K133443 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2013
Decision Date July 10, 2014
Days to Decision 240 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KMF — Bandage, Liquid
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5090

Similar Devices — KMF Bandage, Liquid

All 221
TearRepair Liquid Skin Protectant
K241916 · Optmed, Inc. · Sep 2024
Rochal Bioshield Silicone Film
K182733 · Rochal Industries, LLC · Jun 2019
Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
Cavilon Advanced High Endurance Skin Protectant
K153571 · 3M Healthcare · Aug 2016
Atteris No-Sting Skin Protectant
K160684 · Rochal Industries, LLC · Jul 2016
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K131384 · Kericure, Inc. · Aug 2014