FDA 510(k) Application Details - K162119

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K162119
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	MED-SONICS CORP. 4960 PITTSBURGH AVENUE, SUITE A ERIE, PA 16509 US Other 510(k) Applications for this Company
Contact	JENNIFER RAUTINE 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	08/01/2016
Decision Date	08/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review