BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇺 Hungary

    NeuroLine Disposable Cranial Perforator with Hudson end

    K Number: K213228 · Decision Jun 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    NeuroLine Disposable Cranial Perforator with Hudson end
    K Number
    K213228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
    Date Received
    September 29, 2021
    Decision Date
    June 20, 2022
    Product Code
    HBF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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