FDA 510(k) Application Details - K032209

Device Classification Name System,Planning,Radiation Therapy Treatment

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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
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Regulation Number 892.5050

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Classification Product Code MUJ
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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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