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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREENFIELD MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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. - 2. To be used on a temporary and emergency basis in the management of an open pneumothorax condition. - 3. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.
    Device Description
    Not Found
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