VOROSCOPE(TM)— 510(k) K871735

Name: FDA 510(k) clearance K871735
Creator: U.S. Food and Drug Administration
Published: 1987-06-03

Substantially Equivalent

Australian Biomedical Corporation , Ltd.

FDA 510(k) clearance K871735 for VOROSCOPE(TM), Substantially Equivalent on 1987-06-03. Applicant: Australian Biomedical Corporation , Ltd.. Device class: 2.

Clearance details

Applicant: Australian Biomedical Corporation , Ltd.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1987-05-05
Decision date: 1987-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

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