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

    HEMOR-RITE CRYOTHERAPHY

    K Number: K042564 · Decision Sep 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    374

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    Basic Information

    Device Name
    HEMOR-RITE CRYOTHERAPHY
    K Number
    K042564
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fama Holdings International Corp
    Date Received
    September 21, 2004
    Decision Date
    September 30, 2005
    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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