510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
428
Ophthalmic
272
Orthopedic
2701
Pathology
52
Physical Medicine
514
Radiology
2320
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
368
FXX
Mask, Surgical
354
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Saeshin Precision Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Saeshin Precision Co., Ltd. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 2009
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Saeshin Precision Co., Ltd.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 20, 2024
Traus SSG10 Surgical System
K233153
·
HBC
Neurology
·
359d
Cleared
Sep 16, 2024
Traus SSG30 Surgical System
K232938
·
HBC
Neurology
·
362d
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18
Dental
16
Neurology
2