Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K043244 |
Device Name |
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420 -9192
|
|
Applicant Contact |
ARTHUR EILINSFELD |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 HAYDEN AVE. |
LEXINGTON,
MA
02420 -9192
|
|
Correspondent Contact |
ARTHUR EILINSFELD |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/23/2004 |
Decision Date | 12/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|