BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GORE® ENFORM PREPERITONEAL Biomaterial

    Reg #: 3003910212 · FEI: 3003910212 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    W. L. GORE & ASSOCIATES, INC.
    Registration Number
    3003910212
    FEI Number
    3003910212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    301 AIRPORT RD.
    City
    ELKTON
    State
    MD
    ZIP
    21921
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222919

    Owner / Operator

    Firm Name
    W. L. GORE & ASSOCIATES, INC.
    Operator Number
    9925013
    Address
    1505 North Fourth Street
    City
    Flagstaff
    State
    AZ
    Postal Code
    86004
    Country
    US
    Correspondent
    Lisa Wells

    Products

    Device Name Product Code
    Mesh, Surgical, Absorbable, Abdominal Hernia OWT
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery OXF
    Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction OWZ

    Proprietary Names

    GORE® ENFORM PREPERITONEAL Biomaterial GORE® ENFORM INTRAPERITONEAL Biomaterial

    Establishment Types

    Manufacture Medical Device