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510(k) Data Aggregation

    K Number
    K022043
    Device Name
    SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
    Manufacturer
    MEDENNIUM, INC.
    Date Cleared
    2002-10-18

    (116 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDENNIUM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum. SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.
    Device Description
    Not Found
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