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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 K181049
Device Name Spectra Optia Apheresis System
Applicant
Terumobct, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Applicant Contact Nicholas Wong
Correspondent
Terumobct, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Correspondent Contact Nicholas Wong
Classification Product Code
LKN  
Date Received04/20/2018
Decision Date 11/01/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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