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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K002194
Device Name TREATVISION
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way M/S E-055
Palo Alto,  CA  94304
Applicant Contact LINDA S NASH
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way M/S E-055
Palo Alto,  CA  94304
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
LHN  
Date Received07/20/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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