FDA 510(k) Application Details - K001006

Device Classification Name System, Radiation Therapy, Radionuclide

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510(K) Number K001006
Device Name System, Radiation Therapy, Radionuclide
Applicant MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO K2K1X8 CA
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Contact E S MARTELL
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Regulation Number 892.5750

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Classification Product Code IWB
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Date Received 03/29/2000
Decision Date 04/27/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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