BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KILTEX CORP.

    Reg #: 1527493 · FEI: 1527493 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    KILTEX CORP.
    Registration Number
    1527493
    FEI Number
    1527493
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2064 KILLIAN ROAD
    City
    Akron
    State
    OH
    ZIP
    44312
    Country
    US

    Regulatory Submissions

    510(k) Number
    K961029

    Owner / Operator

    Firm Name
    KILTEX CORP.
    Operator Number
    1527493
    Address
    2064 KILLIAN RD., --
    City
    Akron
    State
    OH
    Postal Code
    44312
    Country
    US
    Correspondent
    TIMOTHY J KILLIAN

    Products

    Device Name Product Code
    Tonometer, Manual HKY
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Tono Pen Probe Covers Kiltex Probe Cover

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device