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996
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632
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621
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528
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522
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Polymer Patient Examination Glove
490
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485
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Intervertebral Fusion Device...
451
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443
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510k Database
Manufacturers
US
O'Tec Corp.
Medical Device Manufacturer
·
US , Oberlin , KS
O'Tec Corp. - FDA 510(k) Cleared Devices
23 submissions
·
18 cleared
·
Since 1988
23
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - O'Tec Corp.
Physical Medicine
✕
2
devices
1-2 of 2
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Cleared
Aug 19, 1994
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293
·
IOR
Physical Medicine
·
42d
Cleared
Aug 02, 1988
WHEELCHAIR BCW 6000
K883034
·
IOR
Physical Medicine
·
14d
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23
Orthopedic
21
Physical Medicine
2