Cleared Traditional

BAND-AID(TM) BRAND ADHESIVE BANDAGE

K940536 · Johnson & Johnson Consumer Products, Inc. · General & Plastic Surgery
Oct 1994
Decision
238d
Days
Class 1
Risk

About This 510(k) Submission

K940536 is an FDA 510(k) clearance for the BAND-AID(TM) BRAND ADHESIVE BANDAGE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Johnson & Johnson Consumer Products, Inc. (North Brunswick, US). The FDA issued a Cleared decision on October 3, 1994, 238 days after receiving the submission on February 7, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K940536 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1994
Decision Date October 03, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGX — Tape And Bandage, Adhesive
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5240

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