AMALGAPHASE— 510(k) K921538

Substantially Equivalent

Saskan Amalgam Alloys, Inc.

FDA 510(k) clearance K921538 for AMALGAPHASE, Substantially Equivalent on 1992-08-10. Applicant: Saskan Amalgam Alloys, Inc.. Device class: 2.

Clearance details

Applicant: Saskan Amalgam Alloys, Inc.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1992-03-31
Decision date: 1992-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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