FDA 510(k) Application Details - K072913

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K072913
Device Name	Marker, Radiographic, Implantable
Applicant	SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100 TECHNOLOGY CENTER DR. INDIANAPOLIS, IN 46278 US Other 510(k) Applications for this Company
Contact	PAULA A GRAY 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	10/12/2007
Decision Date	01/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review