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    K Number
    K990079
    Device Name
    FASTSEAL CHEST WOUND DRESSING
    Manufacturer
    GREENFIELD MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-12-23

    (346 days)

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

    FASTSEAL CHEST WOUND DRESSING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds.
      1. To be used on a temporary and emergency basis in the management of an open pneumothorax condition.
      1. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter about the "FastSeal Chest Wound Dressing" (K990079) does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a 510(k) clearance document, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include details on performance studies or their methodologies.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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