FDA 510(k) Application Details - K111058

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K111058
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	MED-SONICS CORP 5451 MERWIN LANE, SUITE 203 ERIE, PA 16510 US Other 510(k) Applications for this Company
Contact	WILLIAM A STOLL 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	04/18/2011
Decision Date	03/30/2012
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