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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 K083839
Device Name AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
Original Applicant
C.R. BARD, INC.
13183 harland drive
covington,  GA  30014 6421
Original Contact terri morris
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received12/23/2008
Decision Date 01/15/2009
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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