Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K193482 |
Device Name |
PrisMax System Version 3 |
Applicant |
Baxter Healthcare Corporation |
7601 Northland Drive |
Brooklyn Park,
MN
55428
|
|
Applicant Contact |
Christopher Scavotto |
Correspondent |
Baxter Healthcare Corporation |
7601 Northland Drive |
Brooklyn Park,
MN
55428
|
|
Correspondent Contact |
Christopher Scavotto |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/17/2019 |
Decision Date | 03/13/2020 |
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
|
|
|