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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 K151368
Device Name Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
Applicant
TERUMO BCT
10811 W. COLLINS AVENUE
LAKEWOOD,  CO  80215 -4415
Applicant Contact Nicholas Wong
Correspondent
TERUMO BCT
10811 W. COLLINS AVENUE
LAKEWOOD,  CO  80215 -4415
Correspondent Contact Nicholas Wong
Classification Product Code
LKN  
Date Received05/21/2015
Decision Date 09/11/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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