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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 K111692
Device Name TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
Applicant
Somatex Medical Technologies GmbH
Unterer Winkel 3
Wurmlingen,  DE 78573
Applicant Contact HARALD JUNG
Correspondent
Somatex Medical Technologies GmbH
Unterer Winkel 3
Wurmlingen,  DE 78573
Correspondent Contact HARALD JUNG
Regulation Number878.4300
Classification Product Code
NEU  
Date Received06/16/2011
Decision Date 11/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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