FDA 510(k) Application Details - K030745

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K030745
Device Name Source, Brachytherapy, Radionuclide
Applicant VARIAN MEDICAL SYSTEMS
700 HARRIS STREET
SUITE 109
CHARLOTTESVILLE, VA 22903-1038 US
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Contact VY TRAN
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 03/10/2003
Decision Date 03/12/2003
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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