FDA 510(k) Application Details - K170531

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K170531
Device Name	Dilator, Catheter, Ureteral
Applicant	Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Cori Ragan 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	02/22/2017
Decision Date	08/17/2017
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