Device Classification Name |
Separator, Automated, Blood Cell And Plasma, Therapeutic
|
510(k) Number |
K111702 |
Device Name |
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
Applicant |
FENWAL, INC. |
THREE CORPORATE DRIVE |
LAKE ZURICH,
IL
60047
|
|
Applicant Contact |
Kim Forch |
Correspondent |
FENWAL, INC. |
THREE CORPORATE DRIVE |
LAKE ZURICH,
IL
60047
|
|
Correspondent Contact |
Kim Forch |
Classification Product Code |
|
Date Received | 06/17/2011 |
Decision Date | 03/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|