FDA 510(k) Application Details - K172289

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K172289
Device Name	Stent, Ureteral
Applicant	Q Urological Corporation 15 Kearney Road Needham, MA 02492 US Other 510(k) Applications for this Company
Contact	Scott Epstein 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	07/31/2017
Decision Date	10/04/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review