FDA 510(k) Application Details - K072445

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K072445
Device Name System, Simulation, Radiation Therapy
Applicant NUCLETRON CORP.
8671 ROBERT FULTON DRIVE
COLUMBIA, MD 21046 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 08/30/2007
Decision Date 09/14/2007
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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