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510(k) Data Aggregation

    K Number
    K140907
    Device Name
    LEECH, MEDICINAL
    Manufacturer
    CAROLINA BIOLOGICAL SUPPLY CO.
    Date Cleared
    2015-08-07

    (486 days)

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

    CAROLINA BIOLOGICAL SUPPLY CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.
    Device Description
    The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.
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