GenX-CR— 510(k) K232158

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K232158 for GenX-CR, Substantially Equivalent on 2023-09-13. Applicant: Genoray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2023-07-20
Decision date: 2023-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-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.