UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)— 510(k) K053172

Substantially Equivalent

Owandy Sas

FDA 510(k) clearance K053172 for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE), Substantially Equivalent on 2006-06-09. Applicant: Owandy Sas.

Clearance details

Applicant: Owandy Sas
Product code: Code MUH
Advisory panel: Dental
Date received: 2005-11-14
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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