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

    MOERAE SURGICAL MARKING PEN

    K Number: DEN130004 · Decision Dec 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    591

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    Basic Information

    Device Name
    MOERAE SURGICAL MARKING PEN
    K Number
    DEN130004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4670
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Moerae Matrix, Inc.
    Date Received
    May 6, 2013
    Decision Date
    December 18, 2014
    Product Code
    PDW
    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
    PDW Internal Tissue Marker

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    Other Clearances by Moerae Matrix, Inc.

    K Number Device Name
    K131659 MOERAE VEIN PREPARATION KIT