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510(k) K180069

HDR MRI Lumen Marker by C4 Imaging, LLC — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2018
Date Received
January 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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