FDA 510(k) Application Details - K153044

Device Classification Name	More FDA Info for this Device
510(K) Number	K153044
Device Name	Sentimag System, Sentimark Magnetic Marker Systerm
Applicant	ENDOMAGNETICS LTD. THE JEFFREYS BUILDING, COWLEY ROAD CAMBRIDGE CB4 OWS GB Other 510(k) Applications for this Company
Contact	ANDREW SHAWCROSS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2015
Decision Date	03/02/2016
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