Cleared Traditional

KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING

K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Dec 1997
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K973509 is an FDA 510(k) clearance for the KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 4, 1997, 79 days after receiving the submission on September 16, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K973509 FDA.gov
FDA Decision Cleared SN
Date Received September 16, 1997
Decision Date December 04, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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