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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K182672
Device Name ROSA Bracket
Applicant
Gni Co., Ltd.
5f 501, 63-12 Dongtancheomdansaneop 1-Ro
Hwaseong,  KR 18469
Applicant Contact Duk Soo Kim
Correspondent
E&M Consulting
D-1474ho, 230 Simin-Daero, Dongan-Gu
Anyang,  KR 14067
Correspondent Contact Sang Hwa Myung
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/26/2018
Decision Date 11/15/2019
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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