FDA 510(k) Application Details - K013531

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K013531
Device Name System, Simulation, Radiation Therapy
Applicant IMPAC MEDICAL SYSTEMS, INC.
100 WEST EVELYN AVE.
MOUNTAIN VIEW, CA 94041 US
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Contact THOMAS H FARIS
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Regulation Number 892.5840

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Classification Product Code KPQ
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Date Received 10/23/2001
Decision Date 11/07/2001
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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