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510(k) Data Aggregation

    K Number
    K011740
    Device Name
    CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
    Manufacturer
    MEDDEV CORP.
    Date Cleared
    2001-07-02

    (27 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDDEV CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
    Device Description
    MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users. MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices. Implants are made of 99.99% pure gold. They are designed in a receinigular onapo with a opners spherical radius of 12.7 mm to conform to the shape of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.
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