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510(k) Data Aggregation

    K Number
    K230712
    Device Name
    SG Lanset I, SG Lancets, Soft Lancets
    Manufacturer
    Sewon Medical Co.
    Date Cleared
    2023-12-06

    (266 days)

    Product Code
    QRK, ORK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sewon Medical Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.
    Device Description
    The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability. The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.
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