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510(k) Data Aggregation

    K Number
    K011055
    Device Name
    THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
    Manufacturer
    GO MEDICAL INDUSTRIES PTY. LTD.
    Date Cleared
    2001-06-06

    (61 days)

    Product Code
    FCM
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K002803
    Device Name
    THE O'NEIL STERILE FIELD URINARY CATHETER KIT
    Manufacturer
    GO MEDICAL INDUSTRIES PTY. LTD.
    Date Cleared
    2000-12-27

    (110 days)

    Product Code
    FCM
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE O'NEIL STERILE FIELD URINARY CATHETER KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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