FDA 510(k) Application Details - K111692

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K111692
Device Name	Marker, Radiographic, Implantable
Applicant	SOMATEX MEDICAL TECHNOLOGIES GMBH UNTERER WINKEL 3 WURMLINGEN 78573 DE Other 510(k) Applications for this Company
Contact	HARALD JUNG 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	06/16/2011
Decision Date	11/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review