Mesh, Surgical

B. Bruan Surgical, SA

The following data is part of a premarket notification filed by B. Bruan Surgical, Sa with the FDA for Lyograft.

Pre-market Notification Details

Device IDK192452
510k NumberK192452
Device Name:Lyograft
ClassificationMesh, Surgical
Applicant B. Bruan Surgical, SA Carretera Terrassa 121 Rubi,  ES 08191
ContactPau Turon Dols
CorrespondentRobin M Fatzinger
Qreg Consulting, LLC 2192 Martin Drive Gilbertsville,  PA  19525
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-09
Decision Date2020-09-03

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