FDA 510(k) Application Details - K162472

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K162472
Device Name Accelerator, Linear, Medical
Applicant Varian Medical Systems, Inc.
911 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 IYE
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Date Received 09/06/2016
Decision Date 01/19/2017
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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