DURA-PATCH MODEL DP-XXX

Dura Substitute

BRIDGER BIOMED, INC.

The following data is part of a premarket notification filed by Bridger Biomed, Inc. with the FDA for Dura-patch Model Dp-xxx.

Pre-market Notification Details

Device IDK980548
510k NumberK980548
Device Name:DURA-PATCH MODEL DP-XXX
ClassificationDura Substitute
Applicant BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman,  MT  59715
ContactBruce G Ruefer
CorrespondentBruce G Ruefer
BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman,  MT  59715
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-12
Decision Date1998-05-13
Summary:summary

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