Cleared Traditional

K942383 - DERMIVIEW CLEAR TAPE
(FDA 510(k) Clearance)

K942383 · Johnson & Johnson International · General & Plastic Surgery

Aug 1994

Decision

95d

Days

Class 1

Risk

K942383 is an FDA 510(k) clearance for the DERMIVIEW CLEAR TAPE. This device is classified as a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX).

Submitted by Johnson & Johnson International (Arlington, US). The FDA issued a Cleared decision on August 22, 1994, 95 days after receiving the submission on May 19, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K942383 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1994
Decision Date	August 22, 1994
Days to Decision	95 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF