FDA 510(k) Application Details - K973889

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K973889
Device Name Accelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS, INC.
3045 HANOVER ST.
PALO ALTO, CA 94304-1120 US
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Contact CHARLES H WILL
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 10/14/1997
Decision Date 11/21/1997
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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