FDA 510(k) Application Details - K100485

Device Classification Name	More FDA Info for this Device
510(K) Number	K100485
Device Name	GYNECARE TVT EXACT CONTINENCE SYSTEM
Applicant	ETHICON, INC. ROUTE 22 WEST SOMERVILLE, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	SUSAN LIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2010
Decision Date	03/16/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review