One-Fil— 510(k) K232182

Substantially Equivalent

Mediclus Co., Ltd.

FDA 510(k) clearance K232182 for One-Fil, Substantially Equivalent on 2024-01-26. Applicant: Mediclus Co., Ltd..

Clearance details

Applicant: Mediclus Co., Ltd.
Product code: Code KIF
Advisory panel: Dental
Date received: 2023-07-24
Decision date: 2024-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

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