FDA 510(k) Application Details - K142428

Device Classification Name	Lithotriptor, Ultrasonic   More FDA Info for this Device
510(K) Number	K142428
Device Name	Lithotriptor, Ultrasonic
Applicant	CYBERSONICS, INC. 5340 Fryling Road Erie, PA 16510 US Other 510(k) Applications for this Company
Contact	Jeff Vaitekunas Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2014
Decision Date	11/13/2014
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