RAINBOW BLOCK— 510(k) K092513

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K092513 for RAINBOW BLOCK, Substantially Equivalent on 2009-10-09. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2009-08-17
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cypress, 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.