AURECAST 83— 510(k) K972942

Name: FDA 510(k) clearance K972942
Creator: U.S. Food and Drug Administration
Published: 1997-08-28

Substantially Equivalent

Aurex Precious Metal Industries (Pty)Ltd

FDA 510(k) clearance K972942 for AURECAST 83, Substantially Equivalent on 1997-08-28. Applicant: Aurex Precious Metal Industries (Pty)Ltd. Device class: 2.

Clearance details

Applicant: Aurex Precious Metal Industries (Pty)Ltd
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1997-06-20
Decision date: 1997-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edenvale, ZA

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