BVI SLING

Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Bvi Sling.

Pre-market Notification Details

Device IDK002233
510k NumberK002233
Device Name:BVI SLING
ClassificationMesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactDaisy P Sin
CorrespondentDaisy P Sin
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodePAJ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-24
Decision Date2000-10-13

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