FDA 510(k) Application Details - K984532

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K984532
Device Name System,Planning,Radiation Therapy Treatment
Applicant VARIAN MEDICAL SYSTEMS, INC.
3045 HANOVER ST.
PALO ALTO, CA 94304-1120 US
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Contact LINDA S NASH
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 12/21/1998
Decision Date 08/09/1999
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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