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

    ZEROID HEMORRHOIDAL DEVICE

    K Number: K944874 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    308

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    Basic Information

    Device Name
    ZEROID HEMORRHOIDAL DEVICE
    K Number
    K944874
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Appliance Research Corp.
    Date Received
    October 3, 1994
    Decision Date
    August 7, 1995
    Product Code
    LKX
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKX Device, Thermal, Hemorrhoids

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