BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROLENE (Polypropylene) 3D Patch

    Reg #: 2210968 · FEI: 2210968 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ETHICON, INC.
    Registration Number
    2210968
    FEI Number
    2210968
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ROUTE 22 WEST, P.O. Box 151
    City
    Somerville
    State
    NJ
    ZIP
    08876
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181268

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL

    Proprietary Names

    PROLENE (Polypropylene) 3D Patch

    Establishment Types

    Manufacture Medical Device