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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 K180586
Device Name Varian Head Frame
Applicant
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Peter J. Coronado
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Peter J. Coronado
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/05/2018
Decision Date 04/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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