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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 K141019
Device Name AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED
Applicant
Fenwal, Inc.
Three Corporate Dr.
Lake Zurich,  IL  60047
Applicant Contact Kim Forch
Correspondent
Fenwal, Inc.
Three Corporate Dr.
Lake Zurich,  IL  60047
Correspondent Contact Kim Forch
Classification Product Code
LKN  
Subsequent Product Code
GKT  
Date Received04/21/2014
Decision Date 06/10/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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