510(k) K073095

TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 by Somatex Medical Technologies GmbH — Product Code NEU

K073095 is an FDA 510(k) premarket notification submitted by Somatex Medical Technologies GmbH for the device "TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560". The FDA issued a decision of Substantially Equivalent on March 19, 2008. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Somatex Medical Technologies GmbH has at least 6 other 510(k) clearances on record.