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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 K103090
Device Name SPECTRA OPTIA R APHERESIS SYSTEM
Applicant
CARIDIANBCT, INC.
10811 W. COLLINS AVE
LAKEWOOD,  CO  80215
Applicant Contact PATTI ARNDT
Correspondent
CARIDIANBCT, INC.
10811 W. COLLINS AVE
LAKEWOOD,  CO  80215
Correspondent Contact PATTI ARNDT
Classification Product Code
LKN  
Date Received10/19/2010
Decision Date 11/19/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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