RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

Irradiator, Blood To Prevent Graft Versus Host Disease

RAD SOURCE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Rad Source Technologies, Inc. with the FDA for Rad Source X-ray Blood Irradiator, Model Rs-3400.

Pre-market Notification Details

Device IDK082921
510k NumberK082921
Device Name:RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
ClassificationIrradiator, Blood To Prevent Graft Versus Host Disease
Applicant RAD SOURCE TECHNOLOGIES, INC. 6825 SHILOH ROAD EAST SUITE B2 Alpharetta,  GA  30005
ContactRandol E Kirk
CorrespondentRandol E Kirk
RAD SOURCE TECHNOLOGIES, INC. 6825 SHILOH ROAD EAST SUITE B2 Alpharetta,  GA  30005
Product CodeMOT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-01
Decision Date2009-02-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860000737005 K082921 000

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