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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 K182082
Device Name Tumark for Eviva, Tumark for Brevera
Applicant
Somatex Medical Technologies GmbH
Rheinstrasse 7d
Teltow,  DE 14513
Applicant Contact Burkhard Jakob
Correspondent
Somatex Medical Technologies GmbH
Rheinstrasse 7d
Teltow,  DE 14513
Correspondent Contact Burkhard Jakob
Regulation Number878.4300
Classification Product Code
NEU  
Date Received08/02/2018
Decision Date 10/31/2018
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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