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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 K190608
Device Name Mei Ceramic Bracket
Applicant
Orthosun Co., Ltd.
2f, 112, Pyeongni-Gil, Gyeyang-Gu
Incheon,  KR 21008
Applicant Contact Ju-Sung Lee
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number872.5470
Classification Product Code
NJM  
Date Received03/11/2019
Decision Date 11/04/2019
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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