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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K003636
Device Name PORTALVISION
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Applicant Contact LINDA S NASH
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/24/2000
Decision Date 02/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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