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FDA 510(k) Application Details - K081281
Device Classification Name
System,Planning,Radiation Therapy Treatment
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510(K) Number
K081281
Device Name
System,Planning,Radiation Therapy Treatment
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
892.5050
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Classification Product Code
MUJ
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More FDA Info for this Product Code
Date Received
05/06/2008
Decision Date
05/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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