Device Classification Name |
set, perfusion, kidney, disposable
|
510(k) Number |
K170150 |
Device Name |
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags |
Applicant |
S.A.L.F. spa |
Via Marconi 2 |
Cenate Sotto,
IT
24069
|
|
Applicant Contact |
Carmelo Gagliano |
Correspondent |
510k FDA Consulting/Denterprise International, Inc. |
100 East Granada Blvd., Suite 219 |
Ormond Beach,
FL
32176
|
|
Correspondent Contact |
Joyce St. Germain |
Regulation Number | 876.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/17/2017 |
Decision Date | 10/20/2017 |
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
|
|
|