FDA 510(k) Application Details - K060870

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K060870
Device Name Couch, Radiation Therapy, Powered
Applicant MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO K2K1X8 CA
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Contact ROSS KACHANIWSKY
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 03/30/2006
Decision Date 05/15/2006
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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