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.
K241972 07/05/2024 BLUEDIAMOND IMPLANT Megagen Implant Co. Ltd
K234142 12/29/2023 TiGEN Abutment, PMMA 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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