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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, brachytherapy, radionuclide
510(K) Number K120859
Model VC-075-0101-PLCK
Device Name PRE-LOADED GOLD VISICOIL CK MARKER
Applicant
RADIOMED CORPORATION
3150 stage post drive
bartlett,  TN  38133
Contact gordon roberts
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/22/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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