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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 K093064
Device Name TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
Applicant
Somatex Medical Technologies GmbH
1480 Cambridge St.
Cambridge,  MA  02139
Applicant Contact SUSANNE RAAB
Correspondent
Somatex Medical Technologies GmbH
1480 Cambridge St.
Cambridge,  MA  02139
Correspondent Contact SUSANNE RAAB
Regulation Number878.4300
Classification Product Code
NEU  
Date Received09/30/2009
Decision Date 02/17/2010
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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