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510(k) Data Aggregation

    K Number
    K984539
    Device Name
    FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-03-01

    (70 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING

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

    For the management of
    Leg ulcers
    Venous ulcers
    Diabetic ulcers
    Arterial ulcers
    Abrasions
    Second degree burns
    Full and partial thickness pressure ulcers
    Dehisced incisions

    Device Description

    Ferris PolyMem Calcium Alginate Dressing

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Ferris PolyMem Calcium Alginate Dressing. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

    Therefore, I cannot answer your request based on the provided text. The document is a regulatory approval, not a technical report detailing study results.

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