Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K083158 |
Device Name |
EXALIS, SOFTWARE VERSION 1.15 |
Applicant |
GAMBRO, INC. |
14143 DENVER WEST PARKWAY |
LAKEWOOD,
CO
80401
|
|
Applicant Contact |
KAE MILLER |
Correspondent |
GAMBRO, INC. |
14143 DENVER WEST PARKWAY |
LAKEWOOD,
CO
80401
|
|
Correspondent Contact |
KAE MILLER |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 10/24/2008 |
Decision Date | 06/05/2009 |
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
|
|
|