BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medilas H Ball Tip Laser Fiber

    Reg #: 1037955 · FEI: 1037955 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DORNIER MEDTECH AMERICA, INC.
    Registration Number
    1037955
    FEI Number
    1037955
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1155 ROBERTS BLVD.
    City
    KENNESAW
    State
    GA
    ZIP
    30144
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161771

    Owner / Operator

    Firm Name
    Dornier MedTech America, Inc.
    Operator Number
    1037955
    Address
    1155 ROBERTS BLVD., Suite 100
    City
    Kennesaw
    State
    GA
    Postal Code
    30144
    Country
    US
    Correspondent
    John - Hoffer

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Medilas H Ball Tip Laser Fiber

    Establishment Types

    Manufacture Medical Device