BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    MammoSite Radiation Therapy System

    Reg #: 3007200016 · FEI: 3007200016 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hologic Surgical Products Costa Rica, S.R.L.
    Registration Number
    3007200016
    FEI Number
    3007200016
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    562 Parkway, Ave 0, Calle 0, Coyol Free Zone
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K032067

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    US Agent

    Business Name
    Hologic
    Contact Name
    Priscilla Aguilar
    Address
    250 Campus Drive
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    978 8263858

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ

    Proprietary Names

    MammoSite Radiation Therapy System MammoSite 4-6 balloon

    Establishment Types

    Manufacture Medical Device