OSTEON II— 510(k) K112716

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K112716 for OSTEON II, Substantially Equivalent on 2012-01-17. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2011-09-19
Decision date: 2012-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si Yeongtong-Gu, Gyeongg, 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.