PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

Mesh, Surgical

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips Dry - Staple Line Reinforcement.

Pre-market Notification Details

Device IDK971048
510k NumberK971048
Device Name:PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
ClassificationMesh, Surgical
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactBarbara Atzenhoefer
CorrespondentBarbara Atzenhoefer
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 Received1997-03-21
Decision Date1997-05-09
Summary:summary

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