FDA 510(k) Application Details - K053296

Device Classification Name	More FDA Info for this Device
510(K) Number	K053296
Device Name	MENTOR ARIS SUPRAPUBIC SURGICAL KIT
Applicant	MENTOR CORPORATION 201 MENTOR DRIVE SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA A 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	11/25/2005
Decision Date	12/15/2005
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