BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prolaryn Gel Injectable Implant

    Reg #: 2135225 · FEI: 3003407669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Merz North America, Inc.
    Registration Number
    2135225
    FEI Number
    3003407669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4133 Courtney St., Suite 10
    City
    FRANKSVILLE
    State
    WI
    ZIP
    53126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060815

    Owner / Operator

    Firm Name
    Merz North America, Inc.
    Operator Number
    9043404
    Address
    6501 Six Forks Road
    City
    Raleigh
    State
    NC
    Postal Code
    27615
    Country
    US
    Correspondent
    Bonnie Safyurtlu

    Products

    Device Name Product Code
    System, Vocal Cord Medialization MIX

    Proprietary Names

    Prolaryn Gel Injectable Implant

    Establishment Types

    Manufacture Medical Device