Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K003498 |
Device Name |
FRESENIUS OPTIFLUX 200A |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02173
|
|
Applicant Contact |
ARTHUR EILINSFELD |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02173
|
|
Correspondent Contact |
ARTHUR EILINSFELD |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 11/13/2000 |
Decision Date | 01/04/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|