FDA 510(k) Application Details - K051533

Device Classification Name	More FDA Info for this Device
510(K) Number	K051533
Device Name	I-STOP
Applicant	CL MEDICAL 28 AVENUE GENERAL DE GAULLE SAINTE FOY LES LYON 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	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2005
Decision Date	08/11/2005
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