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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K160377
Device Name V-varnish Premium
Applicant
Vericom Co., Ltd.
48, Toegyegongdan 1-Gil,
Chuncheon-Si,  KR 200-944
Applicant Contact Myung-Hwan Oh
Correspondent
Vericom Co., Ltd.
48, Toegyegongdan 1-Gil,
Chuncheon-Si,  KR 200-944
Correspondent Contact Myung-Hwan Oh
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/10/2016
Decision Date 12/02/2016
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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