VERITAS COLLAGEN MATRIX

Mesh, Surgical, Collagen, Staple Line Reinforcement

SYNOVIS SURGICAL INNOVATIONS

The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Veritas Collagen Matrix.

Pre-market Notification Details

Device IDK030879
510k NumberK030879
Device Name:VERITAS COLLAGEN MATRIX
ClassificationMesh, Surgical, Collagen, Staple Line Reinforcement
Applicant SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactAngela Mallery
CorrespondentAngela Mallery
SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeOXE  
Subsequent Product CodeFTM
Subsequent Product CodeOWV
Subsequent Product CodeOXB
Subsequent Product CodePAJ
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-20
Decision Date2003-04-24
Summary:summary

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