KI-20— 510(k) K141482

Substantially Equivalent

Saeyang Microtech Co., Ltd.

FDA 510(k) clearance K141482 for KI-20, Substantially Equivalent on 2015-04-24. Applicant: Saeyang Microtech Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeyang Microtech Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2014-06-04
Decision date: 2015-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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