Cleared Traditional

K843522 - DONWAY SPLINT
(FDA 510(k) Clearance)

K843522 · Australian Biomedical Corporation , Ltd. · Physical Medicine

Feb 1985

Decision

153d

Days

Class 2

Risk

K843522 is an FDA 510(k) clearance for the DONWAY SPLINT, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Australian Biomedical Corporation , Ltd. (Australia, US). The FDA issued a Cleared decision on February 7, 1985, 153 days after receiving the submission on September 7, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K843522 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1984
Decision Date	February 07, 1985
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—