FDA 510(k) Application Details - K070879

Device Classification Name	Catheter, Malecot   More FDA Info for this Device
510(K) Number	K070879
Device Name	Catheter, Malecot
Applicant	C.R. BARD, INC. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 US Other 510(k) Applications for this Company
Contact	JOHN KNORPP Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	FEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2007
Decision Date	04/24/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review