FDA 510(k) Application Details - K201165

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K201165
Device Name	Catheter, Nephrostomy
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2020
Decision Date	12/17/2020
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review