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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name bone marrow collection/transfusion kit
510(k) Number BK170030
Tradenames Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters, Bone Marrow Collection Stand
Device Name Bone Marrow Collection/Transfusion Kit
Original Applicant
Fresenius Kabi
three corporate drive
lake zurich,  IL  60047
Classification Product Code
LWE  
Date Received03/30/2017
Decision Date 07/24/2017
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
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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