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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K143418
Device Name STRONG Dental Handpieces
Applicant
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Daegu,  KR 711-814
Applicant Contact Choi Sae Kwan
Correspondent
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Daegu,  KR 711-814
Correspondent Contact Choi Sae Kwan
Regulation Number872.4200
Classification Product Code
EGS  
Date Received11/28/2014
Decision Date 07/31/2015
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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