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

    GO MEDICAL INDUSTRIES PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    GO MEDICAL INDUSTRIES PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000263
    Device Name
    GO MEDICAL BALLOON INFUSION SYSTEM
    Manufacturer
    GO MEDICAL INDUSTRIES PTY. LTD.
    Date Cleared
    2000-05-09

    (102 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    GO MEDICAL INDUSTRIES PTY. LTD.

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

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