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3204
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2745
Ear, Nose, Throat
464
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2306
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3925
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3575
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779
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774
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492
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165
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958
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System, Image Processing,...
725
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Plate, Fixation, Bone
689
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558
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
461
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Cook, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Cook, Inc. - FDA 510(k) Cleared Devices
190 submissions
·
179 cleared
·
Since 1976
190
Total
179
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook, Inc.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
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Cleared
Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966
·
EOQ
Ear, Nose, Throat
·
112d
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190
Cardiovascular
81
Gastroenterology & Urology
35
General Hospital
22
Anesthesiology
16
Radiology
14
Neurology
8
General & Plastic Surgery
6
Obstetrics & Gynecology
5
Ear, Nose, Throat
1
Pathology
1