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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 K120731
Model GM11006200
Device Name TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way
palo alto,  CA  94304
Contact vy tran
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/09/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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