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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK190362
Tradename Plasmalink Bottle with Locking Luer Adapter
Device Name Empty Containers for the Collection & Processing of Blood/Blood Components
Original Applicant
Fresenius Kabi AG
three corporate dr
lake zurich,  IL  60047 US
Regulation Number864.9100
Classification Product Code
KSR  
Date Received06/24/2019
Decision Date 07/19/2019
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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