MINITAPE EXTRA URETHRAL SLING

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 Minitape Extra Urethral Sling.

Pre-market Notification Details

Device IDK073647
510k NumberK073647
Device Name:MINITAPE EXTRA URETHRAL SLING
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison,  CT  06443
ContactLouis J Mazzarese
CorrespondentLouis J Mazzarese
MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison,  CT  06443
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-03-03
Summary:summary

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