REMEX-GR100— 510(k) K240759

Substantially Equivalent

Remedi Co., Ltd.

FDA 510(k) clearance K240759 for REMEX-GR100, Substantially Equivalent on 2024-05-13. Applicant: Remedi Co., Ltd.. Device class: 2.

Clearance details

Applicant: Remedi Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2024-03-20
Decision date: 2024-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.