Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K182940 |
Device Name |
Surdial DX Hemodialysis System |
Applicant |
Nipro Medical Corporation |
3150 NW 107th Ave. |
Doral,
FL
33172
|
|
Applicant Contact |
Jessica Oswald-McLeod |
Correspondent |
Nipro Medical Corporation |
3150 NW 107th Ave. |
Doral,
FL
33172
|
|
Correspondent Contact |
Jessica Oswald-McLeod |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 10/23/2018 |
Decision Date | 07/19/2019 |
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
|
|
|