OMNISURE URETHRAL SLING, MODEL OTK52

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

MPATHY MEDICAL DEVICES, LTD.

The following data is part of a premarket notification filed by Mpathy Medical Devices, Ltd. with the FDA for Omnisure Urethral Sling, Model Otk52.

Pre-market Notification Details

Device IDK092203
510k NumberK092203
Device Name:OMNISURE URETHRAL SLING, MODEL OTK52
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant MPATHY MEDICAL DEVICES, LTD. LONMAY ROAD Glasgow,  GB G33 4el
ContactCaroline Stretton
CorrespondentCaroline Stretton
MPATHY MEDICAL DEVICES, LTD. LONMAY ROAD Glasgow,  GB G33 4el
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-22
Decision Date2009-08-12
Summary:summary

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