BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇱 Israel

    HEMORRELIEF DEVICE

    K Number: K973590 · Decision Feb 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    5
    Review Days
    136

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    Basic Information

    Device Name
    HEMORRELIEF DEVICE
    K Number
    K973590
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A.Stein - Regulatory Affairs Consulting
    Date Received
    September 22, 1997
    Decision Date
    February 5, 1998
    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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