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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 K192150
Device Name AMICUS Separator System
Applicant
Fresenius Kabi AG
Bad Homburg,  DE 61346
Applicant Contact Aunica Jones
Correspondent
Fenwal, Inc.
Three Corporate Drive
Lake Zurich,  IL  60047
Correspondent Contact Aunica Jones
Classification Product Code
LKN  
Subsequent Product Code
GKT  
Date Received08/09/2019
Decision Date 11/13/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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