Cleared Traditional

NONWOVEN PAD

K980720 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery
Apr 1998
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K980720 is an FDA 510(k) clearance for the NONWOVEN PAD, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on April 15, 1998, 50 days after receiving the submission on February 24, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K980720 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1998
Decision Date April 15, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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