FDA 510(k) Application Details - K093588

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K093588
Device Name System,Planning,Radiation Therapy Treatment
Applicant AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO, CA 92128 US
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Contact DAN OLIVIER
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 11/19/2009
Decision Date 01/11/2010
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 Y
Expedited Review



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