SUPPLE PERI-GUARD PERICARDIUM

Mesh, Surgical

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Supple Peri-guard Pericardium.

Pre-market Notification Details

Device IDK961810
510k NumberK961810
Device Name:SUPPLE PERI-GUARD PERICARDIUM
ClassificationMesh, Surgical
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactBruce A Macfarlane
CorrespondentBruce A Macfarlane
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-10
Decision Date1996-06-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.