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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K201292
Device Name TRAUS SIP20
Applicant
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact GungSan Nam
Correspondent
KMC, Inc.
Rm. # 904, 27
Digital-Ro 27ga-Gil, Guro-Gu
Seoul,  KR 08375
Correspondent Contact DongHa Lee
Regulation Number872.4200
Classification Product Code
EBW  
Subsequent Product Code
EGS  
Date Received05/14/2020
Decision Date 02/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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