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

    BABISTICK

    K Number: K933365 · Decision Oct 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    55
    Review Days
    102

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    Basic Information

    Device Name
    BABISTICK
    K Number
    K933365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Graphic Controls Corp.
    Date Received
    July 9, 1993
    Decision Date
    October 19, 1993
    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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