FDA 510(k) Application Details - K160942

Device Classification Name	More FDA Info for this Device
510(K) Number	K160942
Device Name	Sonablate
Applicant	SonaCare Medical, LLC 10130 PERIMETER PARKWAY, SUITE 250 CHARLOTTE, NC 28216 US Other 510(k) Applications for this Company
Contact	DAVID M. HERNON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2016
Decision Date	12/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review