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510(k) Data Aggregation

    K Number
    K132958
    Device Name
    MEDICINAL LEECHES
    Manufacturer
    BIOPHARM (UK) LTD.
    Date Cleared
    2014-02-19

    (152 days)

    Product Code
    NRN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOPHARM (UK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
    Device Description
    The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.
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