FDA 510(k) Application Details - K083614

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K083614
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	TECHNOMED MEDICAL SYSTEMS, SA 106 EAST 5TH AVENUE MOUNT DORA, FL 32757 US Other 510(k) Applications for this Company
Contact	LYNETTE L HOWARD 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	12/08/2008
Decision Date	07/27/2009
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