GORE POLYPROPYLENE HERNIA MESH

Mesh, Surgical, Polymeric

W. L. GORE & ASSOCIATES, INC.

The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Polypropylene Hernia Mesh.

Pre-market Notification Details

Device IDK043081
510k NumberK043081
Device Name:GORE POLYPROPYLENE HERNIA MESH
ClassificationMesh, Surgical, Polymeric
Applicant W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
ContactMichael Ivey
CorrespondentMichael Ivey
W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-08
Decision Date2004-12-22
Summary:summary

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