T1-CS, T1-C— 510(k) K183475

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K183475 for T1-CS, T1-C, Substantially Equivalent on 2019-08-30. Applicant: Osstem Implant Co., Ltd..

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2018-12-17
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, KR

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