FDA 510(k) Application Details - K093747

Device Classification Name	More FDA Info for this Device
510(K) Number	K093747
Device Name	ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
Applicant	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	JOHN KNORPP Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2009
Decision Date	05/07/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review