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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K230836
Device Name SchurSign Tissue Marker
Applicant
Surgmark GmbH
Maria-Louisen-Straße 122
Hamburg,  DE 22301
Applicant Contact Christine König
Correspondent
Surgmark GmbH
Maria-Louisen-Straße 122
Hamburg,  DE 22301
Correspondent Contact Christine König
Regulation Number878.4300
Classification Product Code
NEU  
Date Received03/27/2023
Decision Date 01/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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