FDA 510(k) Application Details - K190659

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K190659
Device Name	Stent, Ureteral
Applicant	Allwin Medical Devices, Inc. 3305 E. Mira Loma Avenue, Suite 176 Anaheim, CA 92806 US Other 510(k) Applications for this Company
Contact	Digish Mehta 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	03/14/2019
Decision Date	12/02/2019
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review