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510(k) Data Aggregation

    K Number
    K200073
    Device Name
    AugMENTA Penile Implant
    Manufacturer
    Augmenta LLC
    Date Cleared
    2022-09-30

    (990 days)

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

    Augmenta LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.
    Device Description
    The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.
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