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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number BK030040
Tradename Magellan Autologous Platelet Separation System
Device Name Syringe, piston
Original Applicant
Medtronic Sofamor Danek
1800 pyramid place
memphis,  TN  38132
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/26/2003
Decision Date 09/03/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
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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