DONWAY SPLINT— 510(k) K843522

Name: FDA 510(k) clearance K843522
Creator: U.S. Food and Drug Administration
Published: 1985-02-07

Substantially Equivalent

Australian Biomedical Corporation , Ltd.

FDA 510(k) clearance K843522 for DONWAY SPLINT, Substantially Equivalent on 1985-02-07. Applicant: Australian Biomedical Corporation , Ltd.. Device class: 2.

Clearance details

Applicant: Australian Biomedical Corporation , Ltd.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 1984-09-07
Decision date: 1985-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, US

Download summary PDF View on FDA.gov ↗

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