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Repro-Medical System, Inc., Dba Koru Medical Systems
Medical Device Manufacturer
·
US , New York , NY
Repro-Medical System, Inc., Dba Koru Medical Systems - FDA 510(k) Cle...
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Repro-Medical System, Inc., Dba Koru Medical Systems
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 29, 2022
FreedomEdge Syringe Infusion System
K214045
·
FRN
General Hospital
·
123d
Cleared
Nov 09, 2021
FreedomEdge(R) Syringe Infusion System
K211206
·
FRN
General Hospital
·
201d
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General Hospital
2