DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

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, Dura-guard Dura Substitute.

Pre-market Notification Details

Device IDK950956
510k NumberK950956
Device Name:DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
ClassificationDura Substitute
Applicant BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
ContactBruce A Macfarlane
CorrespondentBruce A Macfarlane
BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-02
Decision Date1995-06-02

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