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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Water-Powered
510(k) Number K123695
Device Name TRAUS SIP10
Applicant
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu
Daegu,  KR 704-220
Applicant Contact Y.S. LEE
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number872.4200
Classification Product Code
EKY  
Date Received12/03/2012
Decision Date 12/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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