BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEDBOND EJECTOR KERRISON RONGEUR

    K Number: K933978 · Decision Jan 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    149

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    Basic Information

    Device Name
    NEDBOND EJECTOR KERRISON RONGEUR
    K Number
    K933978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Redmond Neurotechnologies Corp.
    Date Received
    August 16, 1993
    Decision Date
    January 12, 1994
    Product Code
    HAE
    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
    HAE Rongeur, Manual

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