FDA 510(k) Application Details - K191415

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K191415
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Neptune Medical, Inc. 1828 El Camino Real, Suite 508 Burlingame, CA 94010 US Other 510(k) Applications for this Company
Contact	Alex Tilson Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2019
Decision Date	08/30/2019
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