FDA 510(k) Application Details - K113202

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K113202
Device Name	Marker, Radiographic, Implantable
Applicant	FOCAL THERAPEUTICS 4370 ALPINE RD. #101 PORTOLA VALLEY, CA 94028 US Other 510(k) Applications for this Company
Contact	GEORGE HERMANN 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	10/31/2011
Decision Date	02/28/2012
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