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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
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Applicant Contact JOHN C KNORPP
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Correspondent Contact JOHN C KNORPP
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received09/05/2008
Decision Date 09/30/2008
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
Predetermined Change
Control Plan Authorized		 No
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