FDA 510(k) Application Details - K111895

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K111895
Device Name	Marker, Radiographic, Implantable
Applicant	WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 US Other 510(k) Applications for this Company
Contact	MARGE WALLS-WALKER 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	07/05/2011
Decision Date	04/27/2012
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