BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Keratoprosthesis

    Reg #: 1222945 · FEI: 1000120597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    M.E.E.I. Boston Keratoprosthesis
    Registration Number
    1222945
    FEI Number
    1000120597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    243 CHARLES ST
    City
    BOSTON
    State
    MA
    ZIP
    02114
    Country
    US

    Regulatory Submissions

    510(k) Number
    K915062

    Owner / Operator

    Firm Name
    MASSACHUSETTS EYE & EAR INFIRMARY
    Operator Number
    9004589
    Address
    243 CHARLES ST., --
    City
    Boston
    State
    MA
    Postal Code
    02114
    Country
    US
    Correspondent
    Swati Sangwan

    Products

    Device Name Product Code
    Keratoprosthesis, Permanent Implant HQM

    Proprietary Names

    Boston Keratoprosthesis

    Establishment Types

    Manufacture Medical Device