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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 K092203
Device Name OMNISURE URETHRAL SLING, MODEL OTK52
Applicant
MPATHY MEDICAL DEVICES, LTD.
lonmay road
glasgow, 
Contact caroline stretton
Regulation Number878.3300
Classification Product Code
OTN  
Date Received07/22/2009
Decision Date 08/12/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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