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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 K120341
Models GM11007560, GM11007570, GM11007580
Device Name PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
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 Received02/03/2012
Decision Date 04/27/2012
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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