FDA 510(k) Application Details - K190903

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K190903
Device Name	Catheter, Nephrostomy
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Andrew Breidenbach 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	04/08/2019
Decision Date	12/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review