FDA 510(k) Application Details - K032684

Device Classification Name Irradiator, Blood To Prevent Graft Versus Host Disease

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510(K) Number K032684
Device Name Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO K2K1X8 CA
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Contact A. WARBICK-CERONE
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Regulation Number 000.0000

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Classification Product Code MOT
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Date Received 08/29/2003
Decision Date 09/26/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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