Once-Fil Flow— 510(k) K251283

Substantially Equivalent

Mediclus Co., Ltd.

FDA 510(k) clearance K251283 for Once-Fil Flow, Substantially Equivalent on 2025-06-06. Applicant: Mediclus Co., Ltd..

Clearance details

Applicant: Mediclus Co., Ltd.
Product code: Code EBF
Advisory panel: Dental
Date received: 2025-04-25
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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