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

    TRANSTHORACIC/TRANSABDOMINAL-TRAY

    K Number: K833720 · Decision May 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    11
    Review Days
    219

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    Basic Information

    Device Name
    TRANSTHORACIC/TRANSABDOMINAL-TRAY
    K Number
    K833720
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Devices, Inc.
    Date Received
    October 24, 1983
    Decision Date
    May 30, 1984
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

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