TRAUS SIP20— 510(k) K201292

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K201292 for TRAUS SIP20, Substantially Equivalent on 2021-02-11. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2020-05-14
Decision date: 2021-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deagu, 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.