BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DAWELL MEDICAL, LLC

    Reg #: 3033126947 · FEI: 3033126947 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DAWELL MEDICAL, LLC
    Registration Number
    3033126947
    FEI Number
    3033126947
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    18505 Sw 104th Ave Unit 26
    City
    Cutler Bay
    State
    FL
    ZIP
    33157
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250776

    Owner / Operator

    Firm Name
    Dawell Medical, LLC
    Operator Number
    10095313
    Address
    18505 SW 104th Ave Unit 26
    City
    Cutler Bay
    State
    FL
    Postal Code
    33157
    Country
    US
    Correspondent
    Jorge Posada

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    LithoBlast Single-Use Holmium Laser Fibers

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility