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

    GENERAL SURGERY TRAY

    K Number: K842648 · Decision Sep 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    91
    Review Days
    38

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    Basic Information

    Device Name
    GENERAL SURGERY TRAY
    K Number
    K842648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    August 13, 1984
    Decision Date
    September 20, 1984
    Product Code
    LRO
    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
    LRO General Surgery Tray

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