GMD UNIVERSAL URINARY INCONTINENCE SLING

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

GENERIC MEDICAL DEVICE, INC.

The following data is part of a premarket notification filed by Generic Medical Device, Inc. with the FDA for Gmd Universal Urinary Incontinence Sling.

Pre-market Notification Details

Device IDK111219
510k NumberK111219
Device Name:GMD UNIVERSAL URINARY INCONTINENCE SLING
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant GENERIC MEDICAL DEVICE, INC. PO BOX 818 Ocean Shores,  WA  98569
ContactJeff Morgan
CorrespondentJeff Morgan
GENERIC MEDICAL DEVICE, INC. PO BOX 818 Ocean Shores,  WA  98569
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-02
Decision Date2011-06-30
Summary:summary

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