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    K Number
    K070738
    Device Name
    SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
    Manufacturer
    COOK BIOTECH, INC.
    Date Cleared
    2007-04-05

    (20 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIS FACIAL CYLINDER, SIS FACIAL IMPLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "SIS Facial Implant." It is not a study report or clinical trial documentation, so it does not contain information about acceptance criteria, device performance metrics, or study methodologies for an AI/software device.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance process for a physical medical device (surgical mesh) and confirms its substantial equivalence to a predicate device, not on the performance evaluation of a device through a clinical study.

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