FDA 510(k) Application Details - K042851

Device Classification Name	More FDA Info for this Device
510(K) Number	K042851
Device Name	MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
Applicant	MENTOR CORP. 201 MENTOR DRIVE SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA CRAWFORD 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	10/15/2004
Decision Date	11/09/2004
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