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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
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