BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MAINZ HEAD FIXATION BY PERNECZKY

    K Number: K901393 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    MAINZ HEAD FIXATION BY PERNECZKY
    K Number
    K901393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Zeppelin GmbH
    Date Received
    March 26, 1990
    Decision Date
    September 4, 1990
    Product Code
    HBL
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by Zeppelin GmbH

    K Number Device Name
    K901372 LAMINECTOMY RONGEUR