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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 K151723
Device Name Rainbow Trans
Applicant
Genoss
105 Gwanggyo-Ro, Yeongtong-Gu
1f, Gyeonggi R&Db Center / 226, 2f, Gsbc
Suwon-Si,  KR 443-270
Applicant Contact SANGPIL YOON
Correspondent
Ict America, Inc.
180 Sylvan Ave., 2nd Floor
Englewood Cliffs,  NJ  07632
Correspondent Contact DACHAN KWON
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/26/2015
Decision Date 10/28/2015
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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