HELIOFORM GOLD-BASED ALLOY— 510(k) K990670

Name: FDA 510(k) clearance K990670
Creator: U.S. Food and Drug Administration
Published: 1999-04-02

Substantially Equivalent

C. Hafner GmbH & Co.

FDA 510(k) clearance K990670 for HELIOFORM GOLD-BASED ALLOY, Substantially Equivalent on 1999-04-02. Applicant: C. Hafner GmbH & Co.. Device class: 2.

Clearance details

Applicant: C. Hafner GmbH & Co.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1999-03-02
Decision date: 1999-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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