BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Relieva Ultirra Sinus Balloon Catheter

    Reg #: 3005423519 · FEI: 3006165545 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Mentor Texas LP
    Registration Number
    3005423519
    FEI Number
    3006165545
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    555 Airline Drive
    City
    Coppell
    State
    TX
    ZIP
    75019
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111254

    Owner / Operator

    Firm Name
    MENTOR Texas, LP
    Operator Number
    2125050
    Address
    3041 Skyway Cir N, --
    City
    Irving
    State
    TX
    Postal Code
    75038
    Country
    US
    Correspondent
    Debra Smith

    Products

    Device Name Product Code
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    Relieva Ultirra Sinus Balloon Catheter

    Establishment Types

    Repack or Relabel Medical Device