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

    LEECH, MEDICINAL

    K Number: K140907 · Decision Aug 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    486

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    Basic Information

    Device Name
    LEECH, MEDICINAL
    K Number
    K140907
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carolina Biological Supply Co.
    Date Received
    April 8, 2014
    Decision Date
    August 7, 2015
    Product Code
    NRN
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRN Leeches, Medicinal

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