TRAUS SIP20

Controller, Foot, Handpiece And Cord

Saeshin Precision Co., Ltd.

The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Traus Sip20.

Pre-market Notification Details

Device IDK201292
510k NumberK201292
Device Name:TRAUS SIP20
ClassificationController, Foot, Handpiece And Cord
Applicant Saeshin Precision Co., Ltd. 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu,  KR 42921
ContactGungsan Nam
CorrespondentDongha Lee
KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul,  KR 08375
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-14
Decision Date2021-02-11

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