FDA 510(k) Application Details - K013174

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K013174
Device Name	Catheter, Retention Type, Balloon
Applicant	PORGES S.A. USINE DU PONTET BP 89 SARLAT 24203 FR Other 510(k) Applications for this Company
Contact	BERNARD ISMAEL Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2001
Decision Date	01/04/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review