BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    LAITINEN'S TRIGEMINUS STEREOGUIDE

    K Number: K881132 · Decision Aug 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    LAITINEN'S TRIGEMINUS STEREOGUIDE
    K Number
    K881132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Sandstrom Trade & Technology, Inc.
    Date Received
    March 16, 1988
    Decision Date
    August 9, 1988
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Sandstrom Trade & Technology, Inc.

    K Number Device Name
    K881131 THE LAITINEN STEREOTACTIC SYSTEM