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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
FOIA Releasable 510(k) 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
Applicant Contact TERRI MORRIS
Correspondent
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Correspondent Contact TERRI MORRIS
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received12/23/2008
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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