FDA 510(k) Application Details - K220781

Device Classification Name	Dilator, Catheter, Ureteral   More FDA Info for this Device
510(K) Number	K220781
Device Name	Dilator, Catheter, Ureteral
Applicant	Allwin Medical Devices, Inc 3305 E. Miraloma 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	876.5470   More FDA Info for this Regulation Number
Classification Product Code	EZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2022
Decision Date	05/05/2023
Decision	SESE - SUBST EQUIV
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