FDA 510(k) Application Details - K050091

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K050091
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	DIREX SYSTEMS CORP. 11 MERCER RD. NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	LARISA GERSTEIN 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	01/14/2005
Decision Date	03/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review