Rainbow Trans— 510(k) K151723

Substantially Equivalent

Genoss

FDA 510(k) clearance K151723 for Rainbow Trans, Substantially Equivalent on 2015-10-28. Applicant: Genoss. Device class: 2.

Clearance details

Applicant: Genoss
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2015-06-26
Decision date: 2015-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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