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FDA 510(k) Application Details - K121448
Device Classification Name
System,Planning,Radiation Therapy Treatment
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510(K) Number
K121448
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
ELEKTA INC. D/B/A NUCLETRON CORPORATION
7 ST. PAUL ST, STE 1660
BALTIMORE, MD 21202 US
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THOMAS VALENTINE
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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
05/15/2012
Decision Date
07/02/2012
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
N
Expedited Review
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