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3784
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10105
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8816
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6180
Ear, Nose, Throat
2016
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5375
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8550
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6910
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2056
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2629
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16
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641
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1638
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8429
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2195
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1457
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1201
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System, Image Processing,...
1152
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Plate, Fixation, Bone
947
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System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
795
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Prosthesis, Knee,...
788
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Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
724
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Implant, Endosseous, Root-form
699
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510k Database
Manufacturers
US
Fine-Tune
Medical Device Manufacturer
·
US , Deltona , FL
Fine-Tune - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1986
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fine-Tune
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 26, 1986
MODEL CA, HEARING AID
K862095
·
ESD
Ear, Nose, Throat
·
24d
Cleared
Jun 23, 1986
MODEL PC HEARING AID
K861939
·
ESD
Ear, Nose, Throat
·
34d
Cleared
Jun 23, 1986
MODEL HP HEARING AID
K862036
·
ESD
Ear, Nose, Throat
·
25d
Cleared
Apr 23, 1986
MODEL ST HEARING AID
K861254
·
ESD
Ear, Nose, Throat
·
20d
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Ear, Nose, Throat
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