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

    AUTOLANCET

    K Number: K822209 · Decision Aug 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    632
    Review Days
    32

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    Basic Information

    Device Name
    AUTOLANCET
    K Number
    K822209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    July 26, 1982
    Decision Date
    August 27, 1982
    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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