FDA 510(k) Application Details - DEN150011

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150011
Device Name	Sonablate 450
Applicant	SonaCare Medical, LLC. 801 E. Morehead St Suite 201 Charlotte, NC 28202 US Other 510(k) Applications for this Company
Contact	Dawn Byrd Burleson 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	03/23/2015
Decision Date	10/09/2015
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review