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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 K122840
Model 0407
Device Name CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Applicant
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
521 homestead ave.
mount vernon,  NY  10550
Contact chuck smith
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/17/2012
Decision Date 12/14/2012
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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