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Manufacturers
US
The Owenby Co.
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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
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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
Physical Medicine
4
General Hospital
4