AURENORM 68— 510(k) K972945

Name: FDA 510(k) clearance K972945
Creator: U.S. Food and Drug Administration
Published: 1997-11-26

Substantially Equivalent

Aurex Precious Metal Industries (Pty)Ltd

FDA 510(k) clearance K972945 for AURENORM 68, Substantially Equivalent on 1997-11-26. Applicant: Aurex Precious Metal Industries (Pty)Ltd. Device class: 2.

Clearance details

Applicant: Aurex Precious Metal Industries (Pty)Ltd
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1997-06-20
Decision date: 1997-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edenvale, ZA

Download summary PDF View on FDA.gov ↗

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