FDA 510(k) Application Details - K003529

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K003529
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	EDAP TECHNOMED, INC. 100 PINNACLE WAY SUITE 100 NORCROSS, GA 30071 US Other 510(k) Applications for this Company
Contact	Scott J Mindrebo 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	11/16/2000
Decision Date	02/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review