FDA 510(k) Application Details - K151435

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K151435
Device Name System,Planning,Radiation Therapy Treatment
Applicant PHILIPS MEDICAL SYSTEMS MR FINLAND
AYRITIE 4
VANTAA 01510 FI
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Contact JANNE MARVOLA
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 05/28/2015
Decision Date 02/25/2016
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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