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510(k) Data Aggregation

    K Number
    K955772
    Device Name
    CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
    Manufacturer
    TTK BIOMED, LTD.
    Date Cleared
    1996-07-08

    (200 days)

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

    TTK BIOMED, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.
    Device Description
    The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864. Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use. The sterile disposable syringes are made with prolypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.
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