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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
LKN  
Date Received06/17/2011
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
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