Cleared Traditional

ALLKARE(TM) ADHESIVE REMOVER WIPE

K924976 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery
Apr 1993
Decision
201d
Days
Class 1
Risk

About This 510(k) Submission

K924976 is an FDA 510(k) clearance for the ALLKARE(TM) ADHESIVE REMOVER WIPE, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on April 20, 1993, 201 days after receiving the submission on October 1, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.

Submission Details

510(k) Number K924976 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1992
Decision Date April 20, 1993
Days to Decision 201 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KOX — Solvent, Adhesive Tape
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4730