FDA 510(k) Application Details - K102169

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K102169
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	CYBERSONICS, INC. 5368 KUHL RD. ERIE, PA 16510-4703 US Other 510(k) Applications for this Company
Contact	JEFF VAITEKUNAS Other 510(k) Applications for this Contact
Regulation Number	876.4480   More FDA Info for this Regulation Number
Classification Product Code	FFK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2010
Decision Date	08/30/2010
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