FDA 510(k) Application Details - K020971

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K020971
Device Name System,Planning,Radiation Therapy Treatment
Applicant MDS NORDION AB
447 MARCH ROAD
KANATA, ONTARIO K2K 1X8 CA
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Contact E. S MARTELL
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 03/26/2002
Decision Date 06/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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