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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK090004
Tradename MCS+8150 System - Wireless
Device Name Automated Blood Cell Separators
Original Applicant
Haemonetics Corporation Software Solutions
1630 industrial park street
covina,  CA  91722 9144
Regulation Number864.9245
Classification Product Code
GKT  
Date Received01/23/2009
Decision Date 02/20/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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