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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 K132429
FOIA Releasable 510(k) K132429
Device Name SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
Applicant
Terumobct, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Applicant Contact TINA O'BRIEN
Correspondent
Terumobct, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Correspondent Contact TINA O'BRIEN
Classification Product Code
LKN  
Date Received08/05/2013
Decision Date 12/06/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01736657
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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