Cleared Traditional

STRETCH GAUZE BANDAGES

K872875 · Abco Dealers, Inc. · General & Plastic Surgery
Sep 1987
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K872875 is an FDA 510(k) clearance for the STRETCH GAUZE BANDAGES, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 4, 1987, 45 days after receiving the submission on July 21, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number K872875 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1987
Decision Date September 04, 1987
Days to Decision 45 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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