Cleared Traditional

ABDUCTION PILLOW

K823820 · Danek Medical, Inc. · Physical Medicine
Jan 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K823820 is an FDA 510(k) clearance for the ABDUCTION PILLOW, a Splint, Abduction, Congenital Hip Dislocation (Class I — General Controls, product code IOZ), submitted by Danek Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983, 28 days after receiving the submission on December 17, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3665.

Submission Details

510(k) Number K823820 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 1982
Decision Date January 14, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOZ — Splint, Abduction, Congenital Hip Dislocation
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3665