Cleared Traditional

BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP

K941788 · Johnson & Johnson Consumer Products, Inc. · General & Plastic Surgery
Oct 1994
Decision
175d
Days
Class 1
Risk

About This 510(k) Submission

K941788 is an FDA 510(k) clearance for the BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP, 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, 175 days after receiving the submission on April 11, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K941788 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1994
Decision Date October 03, 1994
Days to Decision 175 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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