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510(k) Data Aggregation

    K Number
    K171851
    Device Name
    SOFTXIL
    Manufacturer
    BISTOOL
    Date Cleared
    2018-03-16

    (268 days)

    Product Code
    MIB, FWP, LZK
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTOOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
    Device Description
    SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations. The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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