FDA 510(k) Application Details - K083839

Device Classification Name	More FDA Info for this Device
510(K) Number	K083839
Device Name	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Applicant	C.R. BARD, INC. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 US Other 510(k) Applications for this Company
Contact	TERRI MORRIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2008
Decision Date	01/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review