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

    ROCKET SURGICAL SKIN MARKING PEN

    K Number: K912730 · Decision Nov 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    183
    Registration Numbers
    184
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    ROCKET SURGICAL SKIN MARKING PEN
    K Number
    K912730
    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
    West Texas Lighthouse For the Blind
    Date Received
    June 20, 1991
    Decision Date
    November 7, 1991
    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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