Bright Low Flow— 510(k) K200156

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K200156 for Bright Low Flow, Substantially Equivalent on 2020-10-27. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2020-01-22
Decision date: 2020-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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