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510(k) Data Aggregation

    K Number
    K973076
    Device Name
    EUROMEDICAL HAEMATURIA FOLEY CATHETER
    Manufacturer
    UNOMEDICAL SDN BHD
    Date Cleared
    1998-09-16

    (394 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNOMEDICAL SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
    Device Description
    The Haematuria Foley catheter has a spiral reinforced shaft and eliminates collapse during suctioning from the bladder. The material is exactly the same as the already approved marketed foley catheter. It is available with a variety of tips, Standard, Dufour and Couvelaire.
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    K Number
    K962389
    Device Name
    EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
    Manufacturer
    UNOMEDICAL SDN BHD
    Date Cleared
    1996-11-21

    (154 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNOMEDICAL SDN BHD

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