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510(k) Data Aggregation

    K Number
    K193392
    Device Name
    BioSiCar Silicone Implant
    Manufacturer
    Metalware Technology Corp.
    Date Cleared
    2020-07-20

    (227 days)

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

    Metalware Technology Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioSiCar Silicone Implant is intended for the augmentation of the nasal and/or chin contour.
    Device Description
    BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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