FDA 510(k) Application Details - K030821

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K030821
Device Name System,Planning,Radiation Therapy Treatment
Applicant SIMUPLAN S.L.
MIGUEL HERNANDEZ 25
LA ELIANA VALENCIA 46183 ES
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Contact CONRADO PLA
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 03/14/2003
Decision Date 09/17/2003
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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