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FDA 510(k) Application Details - K032209
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K032209
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
NOMOS CORP.
200 WEST KENSINGER DR.
SUITE 100
CRANBERRY TOWNSHIP, PA 16066 US
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Contact
FRANCIS X DOBSCHA
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
07/18/2003
Decision Date
08/21/2003
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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