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528
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522
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490
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485
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451
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510k Database
Manufacturers
US
Promedic, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Promedic, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
14 cleared
·
Since 1995
16
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Promedic, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 17, 2003
FENESTRATED INFUSION CATHETER
K024190
·
FRN
General Hospital
·
88d
Cleared
Jun 24, 1997
FILTER
K970102
·
CAH
General Hospital
·
162d
Cleared
Jun 14, 1995
PRESSURIZER
K951988
·
KZD
General Hospital
·
48d
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16
Anesthesiology
6
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5
General Hospital
3
Obstetrics & Gynecology
1
General & Plastic Surgery
1