Cleared Traditional

NEOPRENE KNEE SUPPORT

K812423 · Surgical Appliance Industries, Inc. · Physical Medicine
Sep 1981
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K812423 is an FDA 510(k) clearance for the NEOPRENE KNEE SUPPORT, a Joint, Knee, External Brace (Class I — General Controls, product code ITQ), submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 21 days after receiving the submission on August 24, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K812423 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1981
Decision Date September 14, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ITQ — Joint, Knee, External Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475

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