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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 BK080033
Tradename PLASMALINK
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Fenwal, Inc.
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9100
Classification Product Code
KSR  
Date Received07/23/2008
Decision Date 08/22/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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