FDA 510(k) Application Details - K983101

Device Classification Name	Catheter, Urological (Antimicrobial) And Accessories   More FDA Info for this Device
510(K) Number	K983101
Device Name	Catheter, Urological (Antimicrobial) And Accessories
Applicant	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30209 US Other 510(k) Applications for this Company
Contact	GEORGIA C ABERNATHY Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	MJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/1998
Decision Date	11/03/1998
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