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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K041403
Device Name ECLIPSE WITH AAA
Applicant
Varian Medical Systems
3100 Hansen Way
M/S H055
Palo Alto,  CA  94304
Applicant Contact VY TRAN
Correspondent
Varian Medical Systems
3100 Hansen Way
M/S H055
Palo Alto,  CA  94304
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/26/2004
Decision Date 07/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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