BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Boston Band Orthosis

    Reg #: 3001967835 · FEI: 3001967835 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BOSTON BRACE INTERNATIONAL, INCORPORATED
    Registration Number
    3001967835
    FEI Number
    3001967835
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37 Shuman Ave
    City
    Stoughton
    State
    MA
    ZIP
    02072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111609

    Owner / Operator

    Firm Name
    BOSTON BRACE INTERNATIONAL, INCORPORATED
    Operator Number
    9051057
    Address
    37 Shuman Ave, --
    City
    Stoughton
    State
    MA
    Postal Code
    02072
    Country
    US
    Correspondent
    Thomas Morrissey

    Products

    Device Name Product Code
    Orthosis, Cranial MVA

    Proprietary Names

    Boston Band Orthosis

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device