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510(k) Data Aggregation

    K Number
    K964468
    Device Name
    IAMIN WET DRESSING (COPPER-SALINE)
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-02-03

    (89 days)

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

    IAMIN WET DRESSING (COPPER-SALINE)

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

    A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

    Device Description

    lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Lamin® Wet Dressing (Copper-Saline) and does not contain information about a study with acceptance criteria, device performance, sample sizes, expert involvement, or adjudication methods in the context of an AI/algorithm-based device. The document is for a medical dressing, not a software or AI device. Therefore, I cannot generate the requested information based on the input provided.

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