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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 K092607
Device Name AJUST ADJUSTABLE SINGLE INCISION SLING
Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington,  GA  30014
Contact john c knorpp
Regulation Number878.3300
Classification Product Code
PAH  
Date Received08/25/2009
Decision Date 11/20/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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