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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name irradiator, blood to prevent graft versus host disease
510(k) Number K082921
Device Name RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Applicant
RAD SOURCE TECHNOLOGIES, INC.
6825 SHILOH ROAD EAST
SUITE B2
alpharetta,  GA  30005
Applicant Contact randol e kirk
Correspondent
RAD SOURCE TECHNOLOGIES, INC.
6825 SHILOH ROAD EAST
SUITE B2
alpharetta,  GA  30005
Correspondent Contact randol e kirk
Classification Product Code
MOT  
Date Received10/01/2008
Decision Date 02/17/2009
Decision substantially equivalent (SESE)
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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