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FDA 510(k) Application Details - K041997
Device Classification Name
System,Planning,Radiation Therapy Treatment
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510(K) Number
K041997
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 TERRY AVE.
BURLINGTON, MA 01803 US
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Contact
KEVIN J O'CONNELL
Other 510(k) Applications for this Contact
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
07/26/2004
Decision Date
08/27/2004
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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