BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Silk Voice

    Reg #: 3013417188 · FEI: 3013417188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOFREGEN MEDICAL INC.
    Registration Number
    3013417188
    FEI Number
    3013417188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    175 Crossing Boulevard, Suite 510
    City
    Framingham
    State
    MA
    ZIP
    01702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240919

    Owner / Operator

    Firm Name
    Sofregen Medical Inc.
    Operator Number
    10053258
    Address
    175 Crossing Boulevard, Suite 510
    City
    Framingham
    State
    MA
    Postal Code
    01702
    Country
    US
    Correspondent
    Joseph Brown

    Products

    Device Name Product Code
    System, Vocal Cord Medialization MIX

    Proprietary Names

    Silk Voice

    Establishment Types

    Manufacture Medical Device