Cytrans Granules— 510(k) K192597

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K192597 for Cytrans Granules, Substantially Equivalent on 2020-08-17. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2019-09-20
Decision date: 2020-08-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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