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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 K051065
Device Name RAYCELL X-RAY BLOOD IRRADIATOR
Applicant
MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO,  CA K2K1X8
Applicant Contact ROSS KACHANIWSKY
Correspondent
MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO,  CA K2K1X8
Correspondent Contact ROSS KACHANIWSKY
Classification Product Code
MOT  
Date Received04/26/2005
Decision Date 05/26/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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