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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K150636
Device Name VariSeed 9.0
Applicant
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto,  CA  94304
Applicant Contact Peter J. Coronado
Correspondent
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Peter J. Coronado
Regulation Number892.5730
Classification Product Code
KXK  
Subsequent Product Code
MUJ  
Date Received03/11/2015
Decision Date 05/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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