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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, Retropubic Or Transobturator
510(k) Number K093747
Device Name ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact JOHN KNORPP
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Correspondent Contact JOHN KNORPP
Regulation Number878.3300
Classification Product Code
OTN  
Date Received12/04/2009
Decision Date 05/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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