510k
Database
Specialties
Anesthesiology
532
Cardiovascular
1643
Chemistry
359
Dental
1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
952
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Sejong Medical Co., Ltd.
Medical Device Manufacturer
·
KR , Paju-Si
Sejong Medical Co., Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2017
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sejong Medical Co., Ltd.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 28, 2017
LAP-iX Suction Irrigation
K173111
·
HET
Obstetrics & Gynecology
·
60d
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7
General & Plastic Surgery
5
General Hospital
1
Obstetrics & Gynecology
1