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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number BK040068
Tradename Magellan Autologous Platelet Separator System
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Original Applicant
Medtronic Sofamor Danek
1800 pyramid place
memphis,  TN  38132
Regulation Number862.2050
Classification Product Code
JQC  
Date Received08/31/2004
Decision Date 11/09/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
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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