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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 BK090031
Tradename Bone Marrow Collection Kit and Accessories
Device Name Bone Marrow Collection/Transfusion Kit
Original Applicant
Fenwal Inc
three corporate drive
2nd floor
lake zurich,  IL  60047
Classification Product Code
LWE  
Date Received06/23/2009
Decision Date 07/23/2009
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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