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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 K123941
Model 705, 706
Device Name KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
Original Applicant
SPENCER FILLMORE
2670 leavenworth st.
san francisco,  CA  94133
Original Contact christina bernstein
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received12/20/2012
Decision Date 04/30/2013
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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