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510(k) Data Aggregation

    K Number
    K980563
    Device Name
    SKAR-KARE SHEET
    Manufacturer
    LIFE MEDICAL SCIENCES, INC.
    Date Cleared
    1998-05-20

    (96 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE MEDICAL SCIENCES, INC.

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

    SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.

    Device Description

    SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the SKAR-KARE™-SHEET. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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