Cleared Traditional

ASPEN ESMARK BANDAGE

K872868 · Aspen Laboratories, Inc. · General Hospital
Jul 1987
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K872868 is an FDA 510(k) clearance for the ASPEN ESMARK BANDAGE, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on July 31, 1987, 10 days after receiving the submission on July 21, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number K872868 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1987
Decision Date July 31, 1987
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FQM — Bandage, Elastic
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5075

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