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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 K120344
Device Name RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
Original Applicant
RADIADYNE, LLC (SPECIFICATION DEVELOPER)
11931 wickchester lane
houston,  TX  77043
Original Contact stuart r goldman
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
IYE  
Date Received02/03/2012
Decision Date 05/03/2012
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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