FDA 510(k) Application Details - K063712

Device Classification Name	More FDA Info for this Device
510(K) Number	K063712
Device Name	AVAULTA 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	JOHN C KNORPP 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	12/14/2006
Decision Date	03/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review