TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560

Marker, Radiographic, Implantable

SOMATEX MEDICAL TECHNOLOGIES GMBH

The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark Professional, Model 271560, Mr-tumark Professional, Model 601560.

Pre-market Notification Details

Device IDK093064
510k NumberK093064
Device Name:TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
ClassificationMarker, Radiographic, Implantable
Applicant SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge,  MA  02139
ContactSusanne Raab
CorrespondentSusanne Raab
SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge,  MA  02139
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2010-02-17
Summary:summary

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