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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K160079
Device Name rainbow Shine
Applicant
Genoss Co., Ltd.
1f Gyeonggi R&Db Center/226, 2f, Gsbc, 105
Gwanggyo-Ro Yeongton-Gu
Suwon-Si,  KR 443-270
Applicant Contact Byungsun Kim
Correspondent
Genoss Co., Ltd.
1f Gyeonggi R&Db Center/226, 2f, Gsbc, 105
Gwanggyo-Ro Yeongton-Gu
Suwon-Si,  KR 443-270
Correspondent Contact Byungsun Kim
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/14/2016
Decision Date 11/10/2016
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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