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510(k) Data Aggregation

    K Number
    K140097
    Device Name
    AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2014-09-24

    (253 days)

    Product Code
    CBHKNT
    Regulation Number
    868.5770
    Why did this record match?
    Product Code :

    CBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AMT Endotracheal Tube Bridle Retention System is indicated for use in the adult population for securing medically applied oral endotracheal tubes ranging in size from 5 to 10 mm in diameter. Target areas of use include intensive care, operating room, ambulatory units, endoscopy units, burn units, ENT, Gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
    Device Description
    Not Found
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    K Number
    K964399
    Device Name
    DALE ENDOTRACHEAL TUBE HOLDER 270/280
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-01-28

    (85 days)

    Product Code
    CBH
    Regulation Number
    868.5770
    Why did this record match?
    Product Code :

    CBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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