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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K023220
Device Name VARISOURCE BREAST TEMPLATE SYSTEM
Applicant
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304
Applicant Contact LINDA S NASH
Correspondent
Varian Medical Systems
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact LINDA S NASH
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/27/2002
Decision Date 10/25/2002
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
Recalls CDRH Recalls
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