FDA 510(k) Application Details - K190377

Device Classification Name	More FDA Info for this Device
510(K) Number	K190377
Device Name	UroLift System UL400
Applicant	NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Brian Gall Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2019
Decision Date	03/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review