Cleared Traditional

LEATHER I VELCRO SHOE FASTENER REPAIR

K823627 · Fred Sammons, Inc. · Physical Medicine
Dec 1982
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K823627 is an FDA 510(k) clearance for the LEATHER I VELCRO SHOE FASTENER REPAIR, a Adaptor, Dressing (Class I — General Controls, product code ILD), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 22 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K823627 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date December 28, 1982
Days to Decision 22 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