FDA 510(k) Applications Submitted by Jae Ho Lee

FDA 510(k) Number Submission Date Device Name Applicant
K203565 12/07/2020 Surgical 3D Mask Inno Lifecare
K211556 05/19/2021 N2 MegaGen Implant Co., Ltd.
K172435 08/11/2017 Galaxy R Digital Radiography Upgrade MEDIEN INTERNATIONAL CO LTD
K220846 03/23/2022 CORE-SNARE Incore Co., Ltd.
K221054 04/11/2022 CORE-INJECTOR Incore Co., Ltd.
K211148 04/19/2021 CORE-Trocar Incore CO., LTD.
K213338 10/07/2021 CORE-CLIP Incore Co., Ltd.
K150033 01/09/2015 Air Compressible Limb Therapy System DAESUNG MAREF CO., LTD.
K160178 01/27/2016 Lympha-Flow(LF1200) DaeSung Maref Co., Ltd
K160180 01/27/2016 Intermittent Pneumatic Compression system DaeSung Maref Co., Ltd
K150980 04/14/2015 Venous Assist System DAESUNG MAREF CO., LTD.


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