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510(k) Data Aggregation

    K Number
    K983276
    Device Name
    HYDROFERA BACTERISTATIC NASAL DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1999-09-14

    (362 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROFERA BACTERISTATIC NASAL DRESSING

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

    POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.

    Device Description

    BACTERISTATIC NASAL DRESSING

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Bacteristatic Nasal Dressing." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any information related to multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    This document is purely a regulatory clearance notice and does not delve into the specific technical or clinical study data that would inform such a description.

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