510k
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Anesthesiology
550
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1723
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386
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1390
Ear, Nose, Throat
256
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990
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2232
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2093
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127
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104
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8
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474
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985
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443
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286
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3064
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52
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515
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2505
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156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
365
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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CG Bio Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
CG Bio Co., Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2013
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - CG Bio Co., Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 13, 2013
KULAVAC
K122490
·
OMP
General & Plastic Surgery
·
455d
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5
Orthopedic
3
Neurology
1
General & Plastic Surgery
1