Cleared Traditional

DERMIVIEW HYPOALLERGENIC CLEAR TAPE

K944587 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery
Oct 1995
Decision
406d
Days
Class 1
Risk

About This 510(k) Submission

K944587 is an FDA 510(k) clearance for the DERMIVIEW HYPOALLERGENIC CLEAR TAPE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on October 30, 1995, 406 days after receiving the submission on September 19, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K944587 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1994
Decision Date October 30, 1995
Days to Decision 406 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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