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510(k) Data Aggregation

    K Number
    K981833
    Device Name
    SILIMED NASAL L SHAPED IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-06-26

    (31 days)

    Product Code
    FZE
    Regulation Number
    878.3680
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SILIMED NASAL L SHAPED IMPLANT

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

    The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.

    Device Description

    Silimed Nasal "L" Shaped Implant

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to SILIMED, LLC regarding a Nasal "L" Shaped Implant. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    The letter is primarily focused on:

    • Confirming that the device is substantially equivalent to legally marketed predicate devices.
    • Informing SILIMED, LLC of their ability to market the device.
    • Outlining the general controls and regulations they must adhere to.
    • Stating the intended use of the device: "augmentation and reconstruction of the nasal contour."

    Therefore, I cannot provide the requested information based on the input text.

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