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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 BK980039
Tradename Medusa 2000 Srimport, Version 1.2
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Sanguin International
1020 sherman avenue
hamden,  CT  06514
Regulation Number864.9165
Classification Product Code
MMH  
Date Received11/19/1998
Decision Date 06/11/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
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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