FDA 510(k) Application Details - K191187

Device Classification Name	Catheter, Ureteral, Gastro-Urology   More FDA Info for this Device
510(K) Number	K191187
Device Name	Catheter, Ureteral, Gastro-Urology
Applicant	Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 US Other 510(k) Applications for this Company
Contact	John Hoffer Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2019
Decision Date	09/18/2019
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