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

    MAJOR BASIN TRAY

    K Number: K912104 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    30
    Review Days
    88

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    Basic Information

    Device Name
    MAJOR BASIN TRAY
    K Number
    K912104
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Device Inspection Co., Inc.
    Date Received
    May 13, 1991
    Decision Date
    August 9, 1991
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

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