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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 K001643
Device Name VARIS 1.4G
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY M/S H-055
PALO ALTO,  CA  94304 -1129
Applicant Contact LINDA S NASH
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY M/S H-055
PALO ALTO,  CA  94304 -1129
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/30/2000
Decision Date 06/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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