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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 K071079
FOIA Releasable 510(k) K071079
Device Name SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
Applicant
GAMBRO BCT, INC.
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215 -4415
Applicant Contact PATTI L ARNDT
Correspondent
GAMBRO BCT, INC.
10810 WEST COLLINS AVE.
LAKEWOOD,  CO  80215 -4415
Correspondent Contact PATTI L ARNDT
Classification Product Code
LKN  
Date Received04/17/2007
Decision Date 08/02/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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