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3675
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9935
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8642
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6125
Ear, Nose, Throat
1987
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5241
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8312
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6719
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1998
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2558
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16
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1887
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1464
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12431
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635
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1600
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8282
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2178
Categories
GEX
Powered Laser Surgical Instrument
1400
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1179
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System, Image Processing,...
1136
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Plate, Fixation, Bone
944
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System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
794
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
721
DZE
Implant, Endosseous, Root-form
699
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510k Database
Manufacturers
US
Qualitone, Inc.
Medical Device Manufacturer
·
US , Minneapolis , MN
Qualitone, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1994
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qualitone, Inc.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
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Cleared
Aug 09, 1994
THE CANAL (C.I.C.) AKA/HIDDEN EAR
K941107
·
ESD
Ear, Nose, Throat
·
155d
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Ear, Nose, Throat
1