BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPS-1

    Reg #: 3010680515 · FEI: 3010680515 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    US SPECIALTY FORMULATIONS
    Registration Number
    3010680515
    FEI Number
    3010680515
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1401 S Albert St
    City
    Allentown
    State
    PA
    ZIP
    18103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091656

    Owner / Operator

    Firm Name
    US SPECIALTY FORMULATIONS
    Operator Number
    10084330
    Address
    1401 S Albert St
    City
    Allentown
    State
    PA
    Postal Code
    18103
    Country
    US
    Correspondent
    KYLE FLANIGAN

    Products

    Device Name Product Code
    Set, Perfusion, Kidney, Disposable KDL

    Proprietary Names

    SPS-1

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)