PREMIUM FLEXI-TOUGH— 510(k) K854530

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K854530 for PREMIUM FLEXI-TOUGH, Substantially Equivalent on 1986-03-04. Applicant: The Hygenic Corp..

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EGD
Advisory panel: Dental
Date received: 1985-11-13
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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