FDA 510(k) Application Details - K123038

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K123038
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	EMS ELECTRO MEDICAL SYSTEMS SA 225 Turnpike Road Southborough, MA 01772 US Other 510(k) Applications for this Company
Contact	SUZANNE GOODMAN 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	09/28/2012
Decision Date	01/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review