FDA 510(k) Application Details - K063079

Device Classification Name	More FDA Info for this Device
510(K) Number	K063079
Device Name	I-STOP TRANS OBTURATOR MALE SLING
Applicant	CL MEDICAL 28 AVENUE GENERAL DE GAULLE SAINTE FOY LES LYON F-69110 FR Other 510(k) Applications for this Company
Contact	VINCENT GORIA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2006
Decision Date	11/07/2006
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