FDA 510(k) Application Details - K200757

Device Classification Name	Catheter, Upper Urinary Tract   More FDA Info for this Device
510(K) Number	K200757
Device Name	Catheter, Upper Urinary Tract
Applicant	DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 US Other 510(k) Applications for this Company
Contact	Sarah Bennett Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2020
Decision Date	10/15/2020
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