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FDA 510(k) Applications Submitted by Hyo Eun Lee
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211812
06/11/2021
BLUEDIAMOND IMPLANT, Abutment Screw
MegaGen Implant Co., Ltd.
K220562
02/28/2022
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
MegaGen Implant Co., Ltd.
K153727
12/28/2015
INTRAcel Premium Fractional RF Micro Needle (FRM) System
JEISYS MEDICAL, INC.
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