FDA 510(k) Application Details - K142198

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K142198
Device Name	Marker, Radiographic, Implantable
Applicant	Covidien LLC 2000 Commonwealth Ave Suite 110 Auburndale, MA 02466 US Other 510(k) Applications for this Company
Contact	Saket Bhatt 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	08/11/2014
Decision Date	10/08/2014
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