FDA 510(k) Application Details - K201410

Device Classification Name Bracket, Ceramic, Orthodontic

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510(K) Number K201410
Device Name Bracket, Ceramic, Orthodontic
Applicant GNI Co., LTD
5F 501, 63-12 Dongtancheomdansaneop 1-RO
Hwaseong 18469 KR
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Contact Duk Soo Kim
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Regulation Number 872.5470

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Classification Product Code NJM
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Date Received 05/28/2020
Decision Date 03/12/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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