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510(k) Data Aggregation

    K Number
    K142435
    Device Name
    3S Safety Syringe with/without Needle
    Date Cleared
    2015-02-20

    (175 days)

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

    Sincere Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3S Safety Syringe with/without Needle is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The 3S Safety Syringe with/without Needle is an integrated needle and piston syringe with an innovative anti-needle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision.
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    K Number
    K142436
    Device Name
    3S Safety Insulin Syringe
    Date Cleared
    2015-02-19

    (174 days)

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

    Sincere Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
    Device Description
    The 3S Safety Insulin Syringe is an integrated needle and piston syringe with an innovative antineedle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision. The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G )
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