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

    MSI SURGI-GRADE UNIVERSAL TRACH TRAY

    K Number: K843561 · Decision Oct 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    44

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    Basic Information

    Device Name
    MSI SURGI-GRADE UNIVERSAL TRACH TRAY
    K Number
    K843561
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Sterilization, Inc.
    Date Received
    September 10, 1984
    Decision Date
    October 24, 1984
    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

    Similar 510(k) Clearances

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    ARTHROSCOPY TRAY

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    Other Clearances by Medical Sterilization, Inc.

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    K843564 MSI SURGI-GRADE SUTURE TRAY
    K843562 MSI SURGI-GRADE DELUXE CUT-DOWN TRAY
    K843563 MSI SURGI-GRADE INCISION & DRAIN TRAY