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510(k) Data Aggregation

    K Number
    K070988
    Device Name
    SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
    Date Cleared
    2007-08-23

    (139 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINCHANG MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SC Profi Fine pen needle is intended for use with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
    Device Description
    The SC Profi Fine pen needles are comprised of a stainless steel needle pointed at both ends from 28 gauge to 31gauge. The double-pointed needle is attached to a plastic hub, which screws on to a compatible pen injector (not supplied with this device). It is designed to fit Type A universal insulin pen injectors. The exposed patient-end needle lengths are 3/16"(5mm), 5/16"(8mm), and 1/2"(12.7mm). The needle tip is covered by a colored plastic protective cap, which is covered by a transparent outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is complete. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and ETO sterilized. It is a disposable device intended for single use only.
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