BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MOLE-MARKER

    K Number: K840651 · Decision Mar 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    394
    Registration Numbers
    394
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    26

    Basic Information

    Device Name
    MOLE-MARKER
    K Number
    K840651
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    NOTATION SYSTEMS, INC.
    Date Received
    February 15, 1984
    Decision Date
    March 12, 1984
    Product Code
    FTY
    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
    FTY Tape, Measuring, Rulers And Calipers

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