FDA 510(k) Application Details - K151657

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

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510(K) Number K151657
Device Name System, Applicator, Radionuclide, Remote-Controlled
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 892.5700

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Classification Product Code JAQ
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Date Received 06/19/2015
Decision Date 08/07/2015
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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