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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K152615
Device Name Vonflex S
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 Number872.3660
Classification Product Code
ELW  
Date Received09/14/2015
Decision Date 11/03/2016
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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