FDA 510(k) Application Details - K012628

Device Classification Name	More FDA Info for this Device
510(K) Number	K012628
Device Name	GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
Applicant	GYNECARE CENTER P.O. BOX 151 SOMERVILLE, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	GREGORY JONES 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	08/13/2001
Decision Date	10/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review