FDA 510(k) Application Details - K141344

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K141344
Device Name	Stent, Ureteral
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	MATT BEAUCHANE Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2014
Decision Date	10/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review