FDA 510(k) Application Details - K133655

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K133655
Device Name System,Planning,Radiation Therapy Treatment
Applicant GMV SOLUCIONES GLOBALES INTERNET S.A.U.
ASTERWEG 19
AMSTERDAM, NOORD HOLLAND 1031 HL NL
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Contact ALBERT KOSTER
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 11/27/2013
Decision Date 01/31/2014
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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