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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 K120993
Device Name GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
Original Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way
palo alto,  CA  94304
Original Contact vy tran
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received04/02/2012
Decision Date 07/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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