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510(k) Data Aggregation

    K Number
    K991604
    Device Name
    EPI-FOAM SILICONE SHEETING
    Manufacturer
    BIODERMIS CORP.
    Date Cleared
    1999-06-09

    (30 days)

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

    EPI-FOAM SILICONE SHEETING

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

    Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Epi-Foam Silicone Sheeting," indicating that it is substantially equivalent to a pre-existing device for the management of hypertrophic and keloid scars.

    The letter does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study, sample sizes, data provenance, ground truth establishment, or expert involvement.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request based on the provided text.

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