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4515
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3346
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2794
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469
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2444
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4131
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3849
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808
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796
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15
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1914
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884
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497
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167
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963
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4789
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System, Image Processing,...
730
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696
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568
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
521
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Prosthesis, Knee,...
517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
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Screw, Fixation, Bone
401
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Manufacturers
US
The Owenby Co.
Medical Device Manufacturer
·
US , Mchenry , IL
The Owenby Co. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1976
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Owenby Co.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 28, 1980
STOCKINETTE, STERILE TWO PLY W/PULL TABS
K801532
·
FQM
General Hospital
·
27d
Cleared
Feb 27, 1979
STOCKINETTE, TUBULAR UNBLEACHED
K790210
·
FQM
General Hospital
·
28d
Cleared
Dec 30, 1976
P.S.M. SURGICAL HOOD
K761070
·
FXY
General Hospital
·
44d
Cleared
Dec 02, 1976
P.S.M. JUSTA COVER
K761072
·
FXP
General Hospital
·
16d
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14
General & Plastic Surgery
6
General Hospital
4
Physical Medicine
4