FDA 510(k) Application Details - K130804

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K130804
Device Name	Dilator, Catheter, Ureteral
Applicant	Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	LAUREN RUSSO Other 510(k) Applications for this Contact
Regulation Number	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2013
Decision Date	05/22/2013
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