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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, simulation, radiation therapy
510(k) Number K033470
Device Name SIMULIX EVOLUTION
Original Applicant
NUCLETRON CORPORATION
8671 robert fulton dr.
columbia,  MD  21046 2133
Original Contact lisa dimmick
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received11/03/2003
Decision Date 02/04/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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