FDA 510(k) Application Details - K190312

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K190312
Device Name	Stent, Ureteral
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	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2019
Decision Date	11/15/2019
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