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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 K160144
Device Name rainbow LS Block
Applicant
Genoss Co., Ltd.
1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro, Yeongtong-Gu,
Suwon-Si,  KR 16229
Applicant Contact HAN YEIN
Correspondent
Ict America, Inc.
180 Sylvan Ave., 2nd Floor
Englewood Cliffs,  NJ  07632
Correspondent Contact KIM BYUNGSUN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/21/2016
Decision Date 07/21/2016
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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