OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050— 510(k) K062834

Name: FDA 510(k) clearance K062834
Creator: U.S. Food and Drug Administration
Published: 2007-04-24

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K062834 for OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050, Substantially Equivalent on 2007-04-24. 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: 2006-09-21
Decision date: 2007-04-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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