SUPRIS RETROPUBIC SLING SYSTEM

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

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Supris Retropubic Sling System.

Pre-market Notification Details

Device IDK111233
510k NumberK111233
Device Name:SUPRIS RETROPUBIC SLING SYSTEM
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
ContactTim Crabtree
CorrespondentTim Crabtree
COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-02
Decision Date2011-06-24
Summary:summary

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