FDA 510(k) Application Details - K150636

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K150636
Device Name Source, Brachytherapy, Radionuclide
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 892.5730

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Classification Product Code KXK
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Date Received 03/11/2015
Decision Date 05/08/2015
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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