Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K982413 |
Device Name |
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS |
Applicant |
GAMBRO HEALTHCARE |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4498
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
GAMBRO HEALTHCARE |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4498
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 07/13/1998 |
Decision Date | 04/21/1999 |
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
|
|
|