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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 K090706
Device Name ONCENTRA SIMULATION 2.3
Applicant
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Applicant Contact ELAINE COLBY
Correspondent
Nucletron Corporation
8671 Robert Fulton Dr.
Columbia,  MD  21046
Correspondent Contact ELAINE COLBY
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received03/17/2009
Decision Date 06/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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