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FDA 510(k) Applications Submitted by Jae Hyun 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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