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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone marrow collection/transfusion kit
510(k) Number BK160042
Tradename Bone Marrow Collection Kit and Stand
Device Name Bone Marrow Collection/Transfusion Kit
Original Applicant
Fresenius Kabi
three corporate drive
lake zurich,  IL  60047
Classification Product Code
LWE  
Date Received05/12/2016
Decision Date 06/09/2016
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
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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