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526
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522
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489
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475
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444
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438
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Manufacturers
US
Bio-Vascular, Inc.
Medical Device Manufacturer
·
US , St. Paul , MN
Bio-Vascular, Inc. - FDA 510(k) Cleared Devices
26 submissions
·
25 cleared
·
Since 1986
26
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio-Vascular, Inc.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 30, 1998
DURA-GUARD - DURAL REPAIR PATCH
K982282
·
GXQ
Neurology
·
30d
Cleared
Dec 24, 1997
DURA-GUARD-DURAL REPAIR PATCH
K973706
·
GXQ
Neurology
·
86d
Cleared
Jun 02, 1995
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
K950956
·
GXQ
Neurology
·
92d
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26
Cardiovascular
11
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8
Neurology
3
Ophthalmic
2
Radiology
1
Obstetrics & Gynecology
1