FDA 510(k) Application Details - K201074

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K201074
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
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	876.5990   More FDA Info for this Regulation Number
Classification Product Code	LNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2020
Decision Date	09/03/2020
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