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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 K050516
Device Name T-SLING
Original Applicant
via fratelli meliga 1/c
chivasso, torino,  IT 10034
Original Contact lorena trabucco
Regulation Number878.3300
Classification Product Code
Date Received03/03/2005
Decision Date 02/03/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No