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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K232938
Device Name Traus SSG30 Surgical System
Applicant
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Daegu,  KR 42921
Applicant Contact Gung San Nam
Correspondent
E & M
D-1471, 230, Simin-Daero, Dongan-Gu
Anyang,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number882.4360
Classification Product Code
HBC  
Date Received09/20/2023
Decision Date 09/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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