Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K171671 |
Device Name |
Prismaflex System 8.10 |
Applicant |
Baxter Healthcare Corporation |
32650 North Wilson Road |
Round Lake,
IL
60073
|
|
Applicant Contact |
Rick Lukacovic |
Correspondent |
Baxter Healthcare Corporation |
32650 North Wilson Road |
Round Lake,
IL
60073
|
|
Correspondent Contact |
Rick Lukacovic |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 06/06/2017 |
Decision Date | 02/23/2018 |
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
|
|
|