ROSA Bracket— 510(k) K182672

Substantially Equivalent

Gni Co., Ltd.

FDA 510(k) clearance K182672 for ROSA Bracket, Substantially Equivalent on 2019-11-15. Applicant: Gni Co., Ltd..

Clearance details

Applicant: Gni Co., Ltd.
Product code: Code NJM
Advisory panel: Dental
Date received: 2018-09-26
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong, KR

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