Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K162488 |
Device Name |
Optiflux dialyzer |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
DENISE OPPERMANN |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
DENISE OPPERMANN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/07/2016 |
Decision Date | 04/06/2017 |
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
|
|
|