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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K192561
Device Name TRAUS SUS20
Applicant
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact DongHa Lee
Correspondent
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Correspondent Contact Jong Woo Choi
Regulation Number872.4120
Classification Product Code
DZI  
Date Received09/17/2019
Decision Date 07/13/2020
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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