SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200

Separator, Automated, Blood Cell And Plasma, Therapeutic

GAMBRO BCT, INC.

The following data is part of a premarket notification filed by Gambro Bct, Inc. with the FDA for Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200.

Pre-market Notification Details

Device IDK071079
510k NumberK071079
Device Name:SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant GAMBRO BCT, INC. 10810 WEST COLLINS AVE. Lakewood,  CO  80215 -4415
ContactPatti L Arndt
CorrespondentPatti L Arndt
GAMBRO BCT, INC. 10810 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 Received2007-04-17
Decision Date2007-08-02
Summary:summary

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