Reon— 510(k) K250763

Substantially Equivalent

C.E.I.B.Med

FDA 510(k) clearance K250763 for Reon, Substantially Equivalent on 2025-05-12. Applicant: C.E.I.B.Med. Device class: 2.

Clearance details

Applicant: C.E.I.B.Med
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-03-13
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul-Si, KR

Download summary PDF View on FDA.gov ↗

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