FDA 510(k) Application Details - K073095

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K073095
Device Name	Marker, Radiographic, Implantable
Applicant	SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	SUSANNE RAAB Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2007
Decision Date	03/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review