TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER

Mesh, Surgical

TI-MESH, INC.

The following data is part of a premarket notification filed by Ti-mesh, Inc. with the FDA for Tilghman Titanium Mesh Skeletal Orbit Liner.

Pre-market Notification Details

Device IDK922308
510k NumberK922308
Device Name:TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
ClassificationMesh, Surgical
Applicant TI-MESH, INC. 76 SPECTRUM RD. Las Vegas,  NV  89101
ContactMary P Morgan
CorrespondentMary P Morgan
TI-MESH, INC. 76 SPECTRUM RD. Las Vegas,  NV  89101
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-15
Decision Date1993-01-12

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