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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K063712
Device Name AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Original Applicant
C.R. BARD, INC.
13183 harland drive
covington,  GA  30014 6421
Original Contact john c knorpp
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received12/14/2006
Decision Date 03/12/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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