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

    PERNECZKY CLIP APPLIER/REMOVER

    K Number: K954658 · Decision Oct 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    364

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    Basic Information

    Device Name
    PERNECZKY CLIP APPLIER/REMOVER
    K Number
    K954658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Von Zeppelin GmbH
    Date Received
    October 10, 1995
    Decision Date
    October 8, 1996
    Product Code
    HCI
    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
    HCI Applier, Aneurysm Clip

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