Spectra Optia Apheresis System

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.

Pre-market Notification Details

Device IDK172590
510k NumberK172590
Device Name:Spectra Optia Apheresis System
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood,  CO  80215
ContactNicholas Wong
CorrespondentNicholas Wong
Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood,  CO  80215 -4415
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-29
Decision Date2018-03-02
Summary:summary

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