VENUS Bracket, ROSE Bracket— 510(k) K201410

Substantially Equivalent

Gni Co., Ltd.

FDA 510(k) clearance K201410 for VENUS Bracket, ROSE Bracket, Substantially Equivalent on 2021-03-12. Applicant: Gni Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gni Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2020-05-28
Decision date: 2021-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Gni Co., Ltd.

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