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

    C-SECTION TRAY

    K Number: K842627 · Decision Sep 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    330
    Same Product Code
    61
    Applicant Total
    91
    Review Days
    82

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    Basic Information

    Device Name
    C-SECTION TRAY
    K Number
    K842627
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    July 6, 1984
    Decision Date
    September 26, 1984
    Product Code
    KDD
    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
    KDD Kit, Surgical Instrument, Disposable

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