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510(k) Data Aggregation

    K Number
    K082587
    Device Name
    AUTO-SAFETY INJECTOR-2 (ASI-2)
    Manufacturer
    MEDICAL HOUSE PRODUCTS LIMITED
    Date Cleared
    2008-10-02

    (24 days)

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

    MEDICAL HOUSE PRODUCTS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard 1 ml long BD Hypak® pre-filled syringes with staked needles. The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
    Device Description
    The ASI-2 is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.
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    K Number
    K060819
    Device Name
    COOL.CLICK 2
    Manufacturer
    MEDICAL HOUSE PRODUCTS LIMITED
    Date Cleared
    2006-06-16

    (81 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL HOUSE PRODUCTS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.
    Device Description
    cool.click 2™ is a needle-free delivery device for Serono growth hormone products. The device delivers the drug product by firing a jet of liquid directly through the skin to the subcutaneous region. The jet is created via a powerful spring acting on a piston inside the nozzle and the liquid is forced out through a small aperture at high speed, creating a very fine, high pressure stream of drug that penetrates the skin. The key difference of the cool.click 2™ Needle-Free Growth Hormone Delivery System is it has a digital display to provide more clear and accurate information to users.
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