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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK090044
Tradename Sunrise Blood Bank version 2.0 SP2
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Eclypsis Corporation
450 lapp road
malvern,  PA  19355
Regulation Number864.9165
Classification Product Code
MMH  
Date Received08/26/2009
Decision Date 11/13/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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