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

    HEMORX COLD PACK

    K Number: K883984 · Decision Dec 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    93

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    Basic Information

    Device Name
    HEMORX COLD PACK
    K Number
    K883984
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Bio-Dyne, Inc.
    Date Received
    September 20, 1988
    Decision Date
    December 22, 1988
    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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