TRAUS SUS10— 510(k) K151171

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K151171 for TRAUS SUS10, Substantially Equivalent on 2015-09-01. Applicant: Saeshin Precision Co., Ltd.. Device class: 2.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2015-05-01
Decision date: 2015-09-01
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.