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510(k) Data Aggregation

    K Number
    K963720
    Device Name
    TRACHEOSTOMY KIT
    Manufacturer
    GRAND MEDICAL PRODUCTS
    Date Cleared
    1996-11-27

    (72 days)

    Product Code
    LRQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LRQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961167
    Device Name
    MEDCARE TRACHEOSTOMY CARE TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-07-02

    (99 days)

    Product Code
    LRQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LRQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
    Device Description
    The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
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