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510(k) Data Aggregation

    K Number
    K013936
    Device Name
    SILVERLEAF CONTACT WOUND DRESSING
    Manufacturer
    SILVERLEAF TECHNOLOGIES INC
    Date Cleared
    2003-03-18

    (475 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SilverLeaf Contact Wound Dressings are non-adherent antibacterial barrier dressings intended for local management of surgical wounds (donor and graft sites, incisions) and dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

    Device Description

    SilverLeaf Contact Wound Dressing

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter for the SilverLeaf Contact Wound Dressing and the Indications for Use form. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as described in your request. This type of information would typically be found in the 510(k) summary or a detailed study report, neither of which is present in the provided text.

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