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510(k) Data Aggregation

    K Number
    K091011
    Device Name
    PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")
    Date Cleared
    2009-04-22

    (13 days)

    Product Code
    FWP, LZK
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.
    Device Description
    The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.
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