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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 K172590
Device Name Spectra Optia Apheresis System
Applicant
Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood,  CO  80215
Applicant Contact Nicholas Wong
Correspondent
Terumo BCT, Inc.
10811 W. Collins Avenue
Lakewood,  CO  80215 -4415
Correspondent Contact Nicholas Wong
Classification Product Code
LKN  
Date Received08/29/2017
Decision Date 03/02/2018
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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