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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 stress urinary incontinence, female, mini-sling
510(k) Number K123179
Model BRD800SI, BRD8055SI
Device Name AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
Original Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington,  GA  30014
Original Contact michele davis
Regulation Number878.3300
Classification Product Code
PAH  
Date Received10/09/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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