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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 K160815
Device Name Interstitial Needles
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 Number892.5700
Classification Product Code
JAQ  
Date Received03/24/2016
Decision Date 03/10/2017
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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