FDA 510(k) Application Details - K163541

Device Classification Name	More FDA Info for this Device
510(K) Number	K163541
Device Name	Magseed Magnetic Marker System
Applicant	ENDOMAGNETICS LTD THE JEFFREYS BUILDING COWLEY ROAD CAMBRIDGE CB4 0WS 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	12/16/2016
Decision Date	01/13/2017
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