Cleared Traditional

POLYMER ADHESIVE BANDAGE

K883391 · Marion Laboratories, Inc. · General & Plastic Surgery
Mar 1989
Decision
226d
Days
Class 1
Risk

About This 510(k) Submission

K883391 is an FDA 510(k) clearance for the POLYMER ADHESIVE BANDAGE, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on March 23, 1989, 226 days after receiving the submission on August 9, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number K883391 FDA.gov
FDA Decision Cleared SN
Date Received August 09, 1988
Decision Date March 23, 1989
Days to Decision 226 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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