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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 K082571
Device Name AVAULTA 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 Received09/05/2008
Decision Date 09/30/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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