Cleared Traditional

BK-2082 FOLDING STOCKING AID

K821856 · Fred Sammons, Inc. · Physical Medicine
Jul 1982
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K821856 is an FDA 510(k) clearance for the BK-2082 FOLDING STOCKING AID, a Adaptor, Dressing (Class I — General Controls, product code ILD), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982, 9 days after receiving the submission on June 23, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K821856 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1982
Decision Date July 02, 1982
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILD — Adaptor, Dressing
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050

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