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510(k) Data Aggregation

    K Number
    K050116
    Device Name
    UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
    Date Cleared
    2005-05-09

    (111 days)

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

    UNIQSAFE BIOMEDITECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNIQSAFE Rotatable, Retractable Safety Syringe (1ml , 3ml , 5ml , 10ml ) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.
    Device Description
    The UNIQSAFE Rotatable, Retractable Safety Syringe is sterile, single-use, disposable , Non-reusable, Manual , Retractable, Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. The UNIQSAFE Rotatable, Retractable Safety Syringe consist of the following major components. m Plunger , n Piston , h adaptor , i O-Ring , r Barrel, w Hub, i Needle a Cap. It is manufactured in size of 1ml ,3ml ,5ml and 10ml volume.
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