Cleared Traditional

NON-WOVEN COMPRESS

K980382 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery
Mar 1998
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K980382 is an FDA 510(k) clearance for the NON-WOVEN COMPRESS, 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 March 9, 1998, 35 days after receiving the submission on February 2, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K980382 FDA.gov
FDA Decision Cleared SN
Date Received February 02, 1998
Decision Date March 09, 1998
Days to Decision 35 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

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