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

    HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS

    K Number: K855150 · Decision Apr 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    96

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    Basic Information

    Device Name
    HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS
    K Number
    K855150
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Hpk International, Inc.
    Date Received
    December 26, 1985
    Decision Date
    April 1, 1986
    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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