VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020

Mesh, Surgical, For Stress Urinary Incontinence, Male

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Virtue Ventral Urethral Elevation Sling System Model 50020.

Pre-market Notification Details

Device IDK101297
510k NumberK101297
Device Name:VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
ClassificationMesh, Surgical, For Stress Urinary Incontinence, Male
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactAngela Byland
CorrespondentAngela Byland
COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeOTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-10
Decision Date2010-06-03
Summary:summary

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