FDA 510(k) Application Details - K083839

Device Classification Name

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510(K) Number 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 US
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Contact TERRI MORRIS
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Regulation Number

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Classification Product Code OTP
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Date Received 12/23/2008
Decision Date 01/15/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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