FDA 510(k) Application Details - K984084

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K984084
Device Name	Catheter, Retention Type, Balloon
Applicant	BARD MEDICAL DIV. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	DONNA J WILSON 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	11/16/1998
Decision Date	02/01/1999
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