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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 K201863
Device Name Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
Applicant
Somatex Medical Technologies GmbH
Hohenzollerndamm 150/151
Berlin,  DE 14199
Applicant Contact David Vasmer
Correspondent
Somatex Medical Technologies GmbH
Hohenzollerndamm 150/151
Berlin,  DE 14199
Correspondent Contact David Vasmer
Regulation Number878.4300
Classification Product Code
NEU  
Date Received07/06/2020
Decision Date 02/18/2021
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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