FDA 510(k) Application Details - K163468

Device Classification Name	Stent,Metallic,Expandable,Duodenal   More FDA Info for this Device
510(K) Number	K163468
Device Name	Stent,Metallic,Expandable,Duodenal
Applicant	Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick IE Other 510(k) Applications for this Company
Contact	Jacinta Kilmartin Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	MUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	05/04/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review