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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 K091180
Device Name MINITAPE URETHRAL SLING
Original Applicant
MPATHY MEDICAL DEVICES, LTD.
lonmay road
queenslie
glasgow,  UK g33 4el
Original Contact caroline stretton
Regulation Number878.3300
Classification Product Code
PAH  
Date Received04/23/2009
Decision Date 07/14/2009
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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