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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 and plasma, therapeutic
510(K) Number K113480
Model 61000
Device Name SPECTRA OPTIA APHERESIS SYSTEM
Applicant
CARIDIANBCT, INC.
10811 w. collins ave
lakewood,  CO  80215
Contact tina o'brien
Classification Product Code
LKN  
Date Received11/23/2011
Decision Date 01/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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