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510(k) Data Aggregation

    K Number
    K071823
    Device Name
    PERMA FACIAL IMPLANTS
    Manufacturer
    Date Cleared
    2007-09-19

    (78 days)

    Product Code
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGISIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Perma Facial Implants are solid silicone implants that are intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.
    Device Description
    The SurgiSil™ Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSil™ Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm. The Perma Facial Implants are individually packaged and sterilized by gamma irradiation and are labeled for single use. The Perma Facial Implants are designed with tapered ends to reduce visibility of the implant ends following implantation. The smooth surface of the implant prevents tissue ingrowth permitting easy removal and/or exchange of the implant. The Perma Facial Implants are ideal for use in soft tissue augmentation anywhere in the face where, in the physician's experience, use of a soft silicone elastomer is appropriate.
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