BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ON CALL CHOSEN LANCING DEVICE

    K Number: K113332 · Decision Apr 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    85
    Review Days
    156

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    Basic Information

    Device Name
    ON CALL CHOSEN LANCING DEVICE
    K Number
    K113332
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ACON Laboratories, Inc.
    Date Received
    November 14, 2011
    Decision Date
    April 18, 2012
    Product Code
    FMK
    Advisory Committee
    General, Plastic Surgery
    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
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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