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4515
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3346
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2794
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4131
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808
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1914
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730
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696
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535
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Powered Laser Surgical Instrument
521
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517
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
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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.
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 07, 1980
RESTRAINT, PROTECTIVE
K801628
·
IQK
Physical Medicine
·
23d
Cleared
Jul 28, 1980
ARM SLING
K801626
·
ILI
Physical Medicine
·
13d
Cleared
Jul 28, 1980
COVER, LIMB
K801627
·
IPM
Physical Medicine
·
13d
Cleared
Jul 21, 1980
ARM SLING
K801531
·
ILI
Physical Medicine
·
20d
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14
General & Plastic Surgery
6
General Hospital
4
Physical Medicine
4