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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 K141938
Device Name SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
Applicant
TERUMO BCT, INC..
10811 WEST COLLINS AVE.
LAKEWOOD,  CO  80215
Applicant Contact PATTI ARNDT
Correspondent
TERUMO BCT, INC..
10811 West Collins Ave.
Lakewood,  CO  80215
Correspondent Contact Nicholas Wong
Classification Product Code
LKN  
Date Received07/17/2014
Decision Date 03/23/2015
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
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