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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
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