510k
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Anesthesiology
550
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1727
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386
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1399
Ear, Nose, Throat
257
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994
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2237
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2094
Hematology
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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444
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286
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3075
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52
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515
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2509
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156
Categories
LZA
Polymer Patient Examination Glove
419
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
359
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Electrosurgical, Cutting &...
312
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
234
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Customfab, Inc.
Medical Device Manufacturer
·
US , Garden Grove , CA
Customfab, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2021
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Customfab, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 11, 2021
Surgical Mask
K203012
·
FXX
General Hospital
·
192d
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General Hospital
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