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510(k) K191797

BiomarC Fiducial Marker by Carbon Medical Technologies — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2019
Date Received
July 3, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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