FUSION FAST— 510(k) K043471

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K043471 for FUSION FAST, Substantially Equivalent on 2005-01-27. Applicant: GC America, Inc..

Clearance details

Applicant: GC America, Inc.
Product code: Code ELW
Advisory panel: Dental
Date received: 2004-12-16
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

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