FDA 510(k) Application Details - K191923

Device Classification Name	More FDA Info for this Device
510(K) Number	K191923
Device Name	EverLift Submucosal Lifting Agent
Applicant	GI Supply 5069 Ritter Road, Suite 104 Mechanicsburg, PA 17055 US Other 510(k) Applications for this Company
Contact	Erika Parry Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2019
Decision Date	06/20/2020
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