FDA 510(k) Application Details - K131020

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K131020
Device Name	Catheter, Retention Type, Balloon
Applicant	DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET ISRAEL 15130 IL Other 510(k) Applications for this Company
Contact	ZOYA LEE 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	04/12/2013
Decision Date	05/09/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review