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Manufacturers
US
The R Group
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Medical Device Manufacturer
·
US , Gainesvilles , FL
The R Group - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1991
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - The R Group
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 30, 1991
POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
K912076
·
DQO
Cardiovascular
·
81d
Cleared
Jul 18, 1991
INJECTOR FILL TUBE
K911549
·
DXT
Cardiovascular
·
101d
Cleared
Mar 25, 1991
VESSEL DILATOR
K905416
·
DRE
Cardiovascular
·
111d
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4
Cardiovascular
3
General Hospital
1