GAM-200— 510(k) K120243

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K120243 for GAM-200, Substantially Equivalent on 2012-06-27. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2012-01-27
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.