One-Stop— 510(k) K253797

Substantially Equivalent

Mediclus Co., Ltd.

FDA 510(k) clearance K253797 for One-Stop, Substantially Equivalent on 2026-02-27. Applicant: Mediclus Co., Ltd..

Clearance details

Applicant: Mediclus Co., Ltd.
Product code: Code MVL
Advisory panel: Unknown
Date received: 2025-11-28
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

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