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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 K102561
Device Name ORTHODONTIC CERAMIC BRACKET
Applicant
HT CO., LTD.
HBI 527, HANYANG UNIV.
1271 SA 1(IL)-DONG SANGNOK-GU
ANSAN-SI, GYEONGGI-DO,  KR 426-791
Applicant Contact JERRY CHOI
Correspondent
HT CO., LTD.
HBI 527, HANYANG UNIV.
1271 SA 1(IL)-DONG SANGNOK-GU
ANSAN-SI, GYEONGGI-DO,  KR 426-791
Correspondent Contact JERRY CHOI
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/07/2010
Decision Date 01/25/2011
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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