Cleared Traditional

DRUSHOE

K790326 · J.E. Hanger & Co. , Ltd. · Physical Medicine
Feb 1979
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K790326 is an FDA 510(k) clearance for the DRUSHOE, a Orthosis, Corrective Shoe (Class I — General Controls, product code KNP), submitted by J.E. Hanger & Co. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1979, 11 days after receiving the submission on February 15, 1979. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K790326 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1979
Decision Date February 26, 1979
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code KNP — Orthosis, Corrective Shoe
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475