FDA 510(k) Application Details - K013644

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K013644
Device Name System,Planning,Radiation Therapy Treatment
Applicant PHILIPS MEDICAL SYSTEMS, INC.
595 MINER RD.
HIGHLAND HGTS., OH 44143 US
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Contact ROBERT L TUROCY
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 11/05/2001
Decision Date 09/12/2002
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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