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 IDK181049
510k NumberK181049
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
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-20
Decision Date2018-11-01
Summary:summary

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