FDA 510(k) Application Details - K061140

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K061140
Device Name Accelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
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 04/24/2006
Decision Date 05/15/2006
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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