FDA 510(k) Application Details - K112839

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K112839
Device Name Accelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
M/S E-110
PALO ALTO, CA 94304-1129 US
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Contact VY TRAN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 09/28/2011
Decision Date 11/14/2011
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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