Cleared Traditional

K974823 - NONWOVEN DRESSING
(FDA 510(k) Clearance)

K974823 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery

Feb 1998

Decision

58d

Days

Class 1

Risk

K974823 is an FDA 510(k) clearance for the NONWOVEN DRESSING, 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 February 20, 1998, 58 days after receiving the submission on December 24, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K974823 FDA.gov
FDA Decision	Cleared SN
Date Received	December 24, 1997
Decision Date	February 20, 1998
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—