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510(k) Data Aggregation

    K Number
    K122837
    Device Name
    AUTOJECT 2 FOR GLASSY SYRINGE
    Manufacturer
    OWEN MUMFORD, LTD.
    Date Cleared
    2012-10-15

    (28 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    OWEN MUMFORD, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Autoject® II for glass syringe is a non-sterile fully automatic injection device. The device is intended for the self-administration of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.
    Device Description
    The 'Autoject® II for glass syringe' is composed of simple plastic injection moulded parts and stainless steel springs. The device is a non-sterile, handheld mechanical device intended for self-administered, subcutaneous delivery of an FDA approved drug. The device is designed for use with 1ml fixed needle pre-filled glass syringe, for use in the home to aid, support and reduce patient liked needle phobia. It has been developed to provide a safe and simple procedure to the patient.
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    K Number
    K011951
    Device Name
    EZ SYRINGE
    Manufacturer
    OWEN MUMFORD, LTD.
    Date Cleared
    2001-08-02

    (42 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    OWEN MUMFORD, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hand held device is intended to aid in the self-administration of drugs from a prefilled BD Hypak 1 ml disposable glass syringe. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe.
    Device Description
    The EZ Syringe O.T.C is a hand held, non-sterile manual device using 1 ml BD Hypak disposable glass pre-filled syringe. The devices are designed for use with the 1 ml BD Hypak disposable glass syringe, and to accommodate self- use in the home by the patient or caregiver. The device incorporates enlarged wings to facilitate gripping and a semi-automatic feature to remove the needle shield of the Hypak syringe. The device contains a number of features which adds to its safety and effectiveness, these are as follows :- - Parking Action of Boot Remover. - Drop Test. - Environmental .
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    K Number
    K000482
    Device Name
    MODIFICATION TO AUTOJECT MINI
    Manufacturer
    OWEN MUMFORD, LTD.
    Date Cleared
    2000-03-06

    (21 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    OWEN MUMFORD, LTD.

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