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510(k) Data Aggregation

    K Number
    K021197
    Device Name
    SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
    Manufacturer
    Date Cleared
    2002-04-26

    (10 days)

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

    HOSUK CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Insulin syringes are intended only for the injection of U-100 insulin.
    Device Description
    The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.
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    K Number
    K002921
    Device Name
    SUREONE INSULIN SYRINGE
    Manufacturer
    Date Cleared
    2000-10-18

    (29 days)

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

    HOSUK CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    Ask a specific question about this device

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