FDA 510(k) Application Details - K060314

Device Classification Name System, Radiation Therapy, Radionuclide

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510(K) Number K060314
Device Name System, Radiation Therapy, Radionuclide
Applicant AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DRIVE
SUITE A-1
SAN DIEGO, CA 92128 US
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Contact DAN OLIVIER
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Regulation Number 892.5750

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Classification Product Code IWB
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Date Received 02/08/2006
Decision Date 04/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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