FDA 510(k) Application Details - K203766

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K203766
Device Name System,Planning,Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304 US
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Contact Peter J. Coronado
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 12/23/2020
Decision Date 02/12/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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