MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

ADVANCED UROSCIENCE, INC.

The following data is part of a premarket notification filed by Advanced Uroscience, Inc. with the FDA for Modification To Brennen Biosynthetic Surgical Mesh Matrix.

Pre-market Notification Details

Device IDK993459
510k NumberK993459
Device Name:MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
ClassificationMesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactKaren E Peterson
CorrespondentKaren E Peterson
ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
Product CodePAG  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-13
Decision Date1999-11-05
Summary:summary

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