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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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