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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K151996
Device Name TAURUS C1
Applicant
Shinhung Company, Ltd.
Shinhung Bldg, 450 Cheongpa-Ro, Jung-Gu
Seoul,  KR 100-858
Applicant Contact SKY SHIN
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number872.6640
Classification Product Code
EIA  
Date Received07/20/2015
Decision Date 01/22/2016
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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