SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET

Separator, Automated, Blood Cell And Plasma, Therapeutic

TERUMO BCT, INC..

The following data is part of a premarket notification filed by Terumo Bct, Inc.. with the FDA for Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set.

Pre-market Notification Details

Device IDK132429
510k NumberK132429
Device Name:SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood,  CO  80215 -4415
ContactTina O'brien
CorrespondentTina O'brien
TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood,  CO  80215 -4415
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-05
Decision Date2013-12-06
Summary:summary

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