PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE— 510(k) K912194

Name: FDA 510(k) clearance K912194
Creator: U.S. Food and Drug Administration
Published: 1991-07-30

Substantially Equivalent

Jelenko Co.

FDA 510(k) clearance K912194 for PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE, Substantially Equivalent on 1991-07-30. Applicant: Jelenko Co.. Device class: 2.

Clearance details

Applicant: Jelenko Co.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1991-05-17
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

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