FDA 510(k) Application Details - K062528

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K062528
Device Name	Marker, Radiographic, Implantable
Applicant	SUROS SURGICAL SYSTEMS, INC. 6100 TECHNOLOGY CENTER DR. INDIANAPOLIS, IN 46278 US Other 510(k) Applications for this Company
Contact	HEIDI STRUNK 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	08/29/2006
Decision Date	01/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review