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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
Applicant
RADIOMED CORPORATION
3150 stage post drive
bartlett,  TN  38133
Applicant Contact gordon roberts
Correspondent
RADIOMED CORPORATION
3150 stage post drive
bartlett,  TN  38133
Correspondent 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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