FDA 510(k) Application Details - K133281

Device Classification Name	More FDA Info for this Device
510(K) Number	K133281
Device Name	NEOTRACT UROLIFT SYSTEM
Applicant	NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	Nancy E Isaac 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	10/25/2013
Decision Date	12/20/2013
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