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FDA 510(k) Application Details - K100092
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K100092
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
BEST NOMOS
ONE BEST DRIVE
PITTSBURGH, PA 15202 US
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Contact
CHI PALKO
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2010
Decision Date
02/23/2010
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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