BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Endolumik Gastric Calibration Tube

    Reg #: 3026671998 · FEI: 3026671998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENDOLUMIK
    Registration Number
    3026671998
    FEI Number
    3026671998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    364 Patteson Dr. #293
    City
    Morgantown
    State
    WV
    ZIP
    26505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222880

    Owner / Operator

    Firm Name
    Endolumik
    Operator Number
    10087525
    Address
    364 Patteson Dr. #293
    City
    Morgantown
    State
    WV
    Postal Code
    26505
    Country
    US
    Correspondent
    Mara McFadden

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Endolumik Gastric Calibration Tube

    Establishment Types

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