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3664
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9920
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8637
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6124
Ear, Nose, Throat
1986
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5234
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8300
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6706
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1998
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2558
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16
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4827
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2949
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1877
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1463
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12429
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635
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1600
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8280
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2169
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GEX
Powered Laser Surgical Instrument
1400
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Electrosurgical, Cutting &...
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
GCJ
Laparoscope, General & Plastic...
718
DZE
Implant, Endosseous, Root-form
698
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510k Database
Manufacturers
US
Novatec, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Novatec, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1979
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Novatec, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 04, 1982
DIGICUFF
K820242
·
DXN
Cardiovascular
·
34d
Cleared
Apr 06, 1979
NOVATEC PRM
K790450
·
JOM
Cardiovascular
·
32d
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Cardiovascular
2