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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
Device Name PRE-LOADED GOLD VISICOIL CK MARKER
Original Applicant
RADIOMED CORPORATION
3150 stage post drive
bartlett,  TN  38133
Original Contact gordon roberts
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/22/2012
Decision Date 04/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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