FDA 510(k) Application Details - K182066

Device Classification Name	Catheter, Suprapubic (And Accessories)   More FDA Info for this Device
510(K) Number	K182066
Device Name	Catheter, Suprapubic (And Accessories)
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47404 US Other 510(k) Applications for this Company
Contact	Carly Powell Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	KOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2018
Decision Date	10/30/2018
Decision	SESK - SUBST EQUIV - KIT
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