Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K123288 |
Device Name |
HEMOCONCENTRATOR |
Applicant |
MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 |
RASTATT,
DE
76437
|
|
Applicant Contact |
INGRID RICHTER |
Correspondent |
MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 |
RASTATT,
DE
76437
|
|
Correspondent Contact |
INGRID RICHTER |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 10/22/2012 |
Decision Date | 06/26/2013 |
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
|
|
|