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510k Database
Manufacturers
US
Rand S.R.L.
Medical Device Manufacturer
·
US , Minneapolis , MN
Rand S.R.L. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rand S.R.L.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 21, 2007
PERFORMER CBP SYSTEM
K070213
·
DTQ
Cardiovascular
·
58d
Cleared
Mar 15, 2006
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
K052555
·
DTQ
Cardiovascular
·
180d
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4
Cardiovascular
2
General Hospital
2