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FDA 510(k) Application Details - K072445
Device Classification Name
System, Simulation, Radiation Therapy
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.5840
More FDA Info for this Regulation Number
Classification Product Code
KPQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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