BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM

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

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Innerlace Biourethral Support System.

Pre-market Notification Details

Device IDK031295
510k NumberK031295
Device Name:BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
ClassificationMesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactFrances E Harrison
CorrespondentFrances E Harrison
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodePAG  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-23
Decision Date2003-05-15
Summary:summary

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