FDA 510(k) Application Details - K171024

Device Classification Name	Lithotriptor, Ultrasonic   More FDA Info for this Device
510(K) Number	K171024
Device Name	Lithotriptor, Ultrasonic
Applicant	Cybersonics, Inc. Knowledge Park, 5340 Fryling Road, Suite 101 Erie, PA 16510 US Other 510(k) Applications for this Company
Contact	Samradni Patil 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	04/05/2017
Decision Date	08/21/2017
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