BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Progel Pleural Air Leak Sealant

    Reg #: 2183469 · FEI: 2183469 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENGINEERED PLASTIC COMPONENTS, INC.
    Registration Number
    2183469
    FEI Number
    2183469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    105 Prospect Way
    City
    Osceola
    State
    WI
    ZIP
    54020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120373

    Owner / Operator

    Firm Name
    Engineered Plastic Components, Inc.
    Operator Number
    10043818
    Address
    105 Prospect Way
    City
    Osceola
    State
    WI
    Postal Code
    54020
    Country
    US

    Products

    Device Name Product Code
    Staple, Implantable GDW

    Proprietary Names

    Progel Pleural Air Leak Sealant

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)