FDA 510(k) Application Details - K201815

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K201815
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 US Other 510(k) Applications for this Company
Contact	John Hoffer 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	07/01/2020
Decision Date	11/20/2020
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