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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 BK940005
Tradename Fenwal Bone Marrow Collection Kit w/ Flexible Pre-filter and Inline Filters and Fenwal Bone Marrow Collection Stand
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 Received01/28/1994
Decision Date 05/18/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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