DURA-GUARD - DURAL REPAIR PATCH

Dura Substitute

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Dura-guard - Dural Repair Patch.

Pre-market Notification Details

Device IDK982282
510k NumberK982282
Device Name:DURA-GUARD - DURAL REPAIR PATCH
ClassificationDura Substitute
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactMary Frick
CorrespondentMary Frick
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-30
Decision Date1998-07-30
Summary:summary

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