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

    CUSTOM TRAYS, KITS

    K Number: K894610 · Decision Mar 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    238

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    Basic Information

    Device Name
    CUSTOM TRAYS, KITS
    K Number
    K894610
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    L H M Ent., Inc.
    Date Received
    July 20, 1989
    Decision Date
    March 15, 1990
    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

    Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.

    INSTRUMENT TRAY LINER

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    SINGLE USE INSTRUMENT TRAY

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    SURGICAL INSTRUMENT TRAY

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    FDA Class 1 ·General, Plastic Surgery

    ARTHROSCOPY TRAY

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    OPEN HEART TRAY

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    HEART CATH TRAY

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    FDA Class 1 ·General, Plastic Surgery
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    K900439 SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
    K894611 CATHETER CARE KITS
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