AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE


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

Correspodent Contact kim forch
Classification Product Code
LKN  
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