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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 BK010037
Tradename Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System.
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215 4498
Regulation Number864.9245
Classification Product Code
GKT  
Date Received09/19/2001
Decision Date 09/24/2003
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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