FDA 510(k) Application Details - K033470

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K033470
Device Name System, Simulation, Radiation Therapy
Applicant NUCLETRON CORPORATION
8671 ROBERT FULTON DR.
COLUMBIA, MD 21046-2133 US
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Contact LISA DIMMICK
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Regulation Number 892.5840

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Classification Product Code KPQ
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Date Received 11/03/2003
Decision Date 02/04/2004
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 Y
Expedited Review



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