Won Young Choi

FDA Filings

This page includes the latest FDA filings for Won Young Choi. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013095958
FEI Number3013095958
NameWon Young Choi
Owner & OperatorDRGEM CORPORATION
Contact Address116-59, Sanho-daero
Gumi-si KR-47 Gyeongsangbugdo 730-906 KR
Official Correspondent
  • JUNG BYUNG - PARK
  • 82-70-82308560-x
US Agent
Importing Logistics Registration
ImporterDRGEM USA INC
Address7018 NW 50th Terrace Gainesville Florida
Gainesville, FL 32653 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7018 NW 50th Terrace
Gainesville, FL 32653 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Won Young Choi [DRGEM CORPORATION]
DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,2019-10-17
Won Young Choi [DRGEM CORPORATION]
SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD2019-09-26
Won Young Choi [DRGEM CORPORATION]
GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S2019-09-26
Won Young Choi [DRGEM CORPORATION]
TOPAZ-32D, TOPAZ-40D2019-05-16
Won Young Choi [DRGEM CORPORATION]
RADMAX2019-03-10
Won Young Choi [DRGEM CORPORATION]
JADE-32, JADE-402019-02-07
Won Young Choi [DRGEM CORPORATION]
DXC-RML2018-07-19
Won Young Choi [DRGEM CORPORATION]
DXC-RMH2018-07-19
Won Young Choi [DRGEM CORPORATION]
DIAMOND-5A, DIAMOND-6A,DIAMOND-8A2011-01-11
Won Young Choi [DRGEM CORPORATION]
PBT-62009-09-04
Won Young Choi [DRGEM CORPORATION]
PBT-42009-09-04
Won Young Choi [DRGEM CORPORATION]
PBT-12009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FM62009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC62009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC42009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC22009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSP2009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSE2009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSA2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS-TM2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS-TA2009-09-04
Won Young Choi [DRGEM CORPORATION]
MXR-352007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-U402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-U322007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C522007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C322007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-822007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-682007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-522007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-322007-05-11

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