TRAUS SIP10— 510(k) K123695

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K123695 for TRAUS SIP10, Substantially Equivalent on 2012-12-18. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EKY
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2012-12-03
Decision date: 2012-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, 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.