FDA 510(k) Application Details - K992751

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K992751
Device Name System, Simulation, Radiation Therapy
Applicant VARIAN ASSOC., INC.
3045 HANOVER ST.
PALO ALTO, CA 94304-1129 US
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Contact LINDA S NASH
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Regulation Number 892.5840

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Classification Product Code KPQ
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Date Received 08/16/1999
Decision Date 02/16/2000
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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