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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 K131689
Device Name MRI MARKER
Applicant
C4 Imaging, LLC
2550 S. Telegraph Rd.
Suite 108
Bloomfield Hills,  MI  48302
Applicant Contact STEPHEN J GOLDNER, JD, RAC
Correspondent
C4 Imaging, LLC
2550 S. Telegraph Rd.
Suite 108
Bloomfield Hills,  MI  48302
Correspondent Contact STEPHEN J GOLDNER, JD, RAC
Regulation Number892.5730
Classification Product Code
KXK  
Date Received06/10/2013
Decision Date 11/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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