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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, simulation, radiation therapy
510(k) Number K851653
Device Name VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP
Applicant
VARIAN ASSOC., INC.
611 HANSEN WAY
P.O. BOX 10800
PALO ALTO,  CA  94303
Applicant Contact MILTON D SIEGEL
Correspondent
VARIAN ASSOC., INC.
611 HANSEN WAY
P.O. BOX 10800
PALO ALTO,  CA  94303
Correspondent Contact MILTON D SIEGEL
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received04/22/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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