Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K121341 |
Device Name |
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM |
Applicant |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
920 WINTER STREET |
WALTHAM,
MA
01854
|
|
Applicant Contact |
DENISE OPPERMANN |
Correspondent |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
920 WINTER STREET |
WALTHAM,
MA
01854
|
|
Correspondent Contact |
DENISE OPPERMANN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/03/2012 |
Decision Date | 12/06/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|