BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SureComfort Freedom

    Reg #: 1722458 · FEI: 1000138447 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALLISON MEDICAL, INC.
    Registration Number
    1722458
    FEI Number
    1000138447
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8091 Shaffer Pkwy
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152877

    Owner / Operator

    Firm Name
    ALLISON MEDICAL, INC.
    Operator Number
    9009434
    Address
    8091 Shaffer Parkway, --
    City
    Littleton
    State
    CO
    Postal Code
    80127
    Country
    US
    Correspondent
    Isaiah M Ray

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    SureComfort Freedom Sure Comfort Pen Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198