FDA 510(k) Application Details - K041971

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K041971
Device Name System,Planning,Radiation Therapy Treatment
Applicant PRODIGM GROUP, INC.
19078 CHAPARRAL DRIVE
PENN VALLEY, CA 95946 US
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Contact LEE POTTS
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 07/22/2004
Decision Date 05/20/2005
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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