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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K190155
Device Name FibermarX Radiopaque Tissue Marker
Applicant
Viscus Biologics, LLC
10000 Cedar Ave.
Cleveland,  OH  44106
Applicant Contact Justin Baker
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/30/2019
Decision Date 02/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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