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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 K180615
Device Name AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
Applicant
Fresenius Kabi USA LLC
Three Corporate Drive
Lake Zurich,  IL  60047
Applicant Contact Kim Forch
Correspondent
Fresenius Kabi USA LLC
Three Corporate Drive
Lake Zurich,  IL  60047
Correspondent Contact Kim Forch
Classification Product Code
LKN  
Subsequent Product Code
GKT  
Date Received03/08/2018
Decision Date 12/04/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02372877
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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