Device Classification Name |
set, perfusion, kidney, disposable
|
510(k) Number |
K211842 |
Device Name |
Servator M SALF Solution |
Applicant |
S.A.L.F. spa |
Via Marconi 2 |
Cenate Sotto,
IT
32069
|
|
Applicant Contact |
Carmelo Gagliano |
Correspondent |
The 510k Consulting, LLC |
1449 Springleaf Drive |
Ormond Beach,
FL
32174
|
|
Correspondent Contact |
Joyce St. Germain |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 06/15/2021 |
Decision Date | 12/20/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|