Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

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 Vision, Tumark Professional, Tumark Q, Tumark Professional Q-shape.

Pre-market Notification Details

Device IDK201863
510k NumberK201863
Device Name:Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
ClassificationMarker, Radiographic, Implantable
Applicant SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 Berlin,  DE 14199
ContactDavid Vasmer
CorrespondentDavid Vasmer
SOMATEX Medical Technologies GmbH Hohenzollerndamm 150/151 Berlin,  DE 14199
Product CodeNEU  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2021-02-18

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