FDA 510(k) Application Details - K181151

Device Classification Name	More FDA Info for this Device
510(K) Number	K181151
Device Name	GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
Applicant	Ethicon Inc Route 22 West Somerville, NJ 08876 US Other 510(k) Applications for this Company
Contact	Debbie Fazen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2018
Decision Date	08/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review