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510(k) Data Aggregation

    K Number
    K080247
    Device Name
    QUIKCLOT NOSEBLEED
    Manufacturer
    Z-MEDICA CORPORATION
    Date Cleared
    2008-02-27

    (27 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUIKCLOT NOSEBLEED

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the document you provided is an FDA notification letter regarding an administrative change to a device's product code. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. Therefore, I cannot extract the requested information.

    To answer your request, I would need a document that describes the device's performance characteristics and the studies conducted to demonstrate its effectiveness and safety.

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