FDA 510(k) Application Details - K013276

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K013276
Device Name	Catheter, Retention Type, Balloon
Applicant	SEWOON MEDICAL CO., LTD. PO BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM 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	10/01/2001
Decision Date	02/15/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review