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

    INSTRUMENT TRAY LINER

    K Number: K971217 · Decision May 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    INSTRUMENT TRAY LINER
    K Number
    K971217
    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
    General Hospital Supply Corp.
    Date Received
    April 2, 1997
    Decision Date
    May 6, 1997
    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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