Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K974584 |
Device Name |
FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS |
Applicant |
FRESENIUS USA, INC. |
2637 SHADELANDS DR. |
WALNUT CREEK,
CA
94598
|
|
Applicant Contact |
VIRGINIA SINGER |
Correspondent |
FRESENIUS USA, INC. |
2637 SHADELANDS DR. |
WALNUT CREEK,
CA
94598
|
|
Correspondent Contact |
VIRGINIA SINGER |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/08/1997 |
Decision Date | 05/14/1998 |
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
|
|
|