BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TrueFit Bolus

    Reg #: 3004555507 · FEI: 3004555507 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EXTOL, INC
    Registration Number
    3004555507
    FEI Number
    3004555507
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    651 Case Karsten Dr.
    City
    Zeeland
    State
    MI
    ZIP
    49464
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243057

    Owner / Operator

    Firm Name
    Extol, Inc
    Operator Number
    10084441
    Address
    651 Case Karsten Dr.
    City
    Zeeland
    State
    MI
    Postal Code
    49464
    Country
    US
    Correspondent
    Dan Klompmaker

    Products

    Device Name Product Code
    System, Planning, Radiation Therapy Treatment MUJ

    Proprietary Names

    TrueFit Bolus TrueFlex Bolus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)