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FDA 510(k) Applications Submitted by GNI Co., LTD
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191041
04/19/2019
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
GNI Co., LTD
K201410
05/28/2020
VENUS Bracket, ROSE Bracket
GNI Co., LTD
K182672
09/26/2018
ROSA Bracket
GNI Co., LTD
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