Initial LiSi Press— 510(k) K153136

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K153136 for Initial LiSi Press, Substantially Equivalent on 2016-06-30. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2015-10-30
Decision date: 2016-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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