Device Classification Name |
pump, infusion
|
510(k) Number |
K200176 |
Device Name |
FREEDOM Integrated Syringe Infusion System |
Applicant |
Repro-Med Systems, Inc., dba KORU Medical Systems |
24 Carpenter Road |
Chester,
NY
10918
|
|
Applicant Contact |
Cynthia Lacatena |
Correspondent |
Repro-Med Systems, Inc., dba KORU Medical Systems |
24 Carpenter Road |
Chester,
NY
10918
|
|
Correspondent Contact |
Kachi Enyinna |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/24/2020 |
Decision Date | 12/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|