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

    DISPOSABLE SKIN MARKER

    K Number: K915066 · Decision May 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    183
    Registration Numbers
    184
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    188

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    Basic Information

    Device Name
    DISPOSABLE SKIN MARKER
    K Number
    K915066
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4660
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Medical Mfg., Inc.
    Date Received
    November 8, 1991
    Decision Date
    May 14, 1992
    Product Code
    FZZ
    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
    FZZ Marker, Skin

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