Cleared Traditional

BLISTERFILM TRANSPARENT DRESSING

K851383 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery
Jul 1985
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K851383 is an FDA 510(k) clearance for the BLISTERFILM TRANSPARENT DRESSING, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on July 5, 1985, 88 days after receiving the submission on April 8, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number K851383 FDA.gov
FDA Decision Cleared SN
Date Received April 08, 1985
Decision Date July 05, 1985
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code NAD — Dressing, Wound, Occlusive
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4020

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