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510(k) Data Aggregation

    K Number
    K010819
    Device Name
    3CC NMT SAFETY SYRINGE
    Date Cleared
    2001-11-08

    (234 days)

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

    NEW MEDICAL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K982431
    Device Name
    NMT SAFETY SYRINGE
    Date Cleared
    1998-11-18

    (128 days)

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

    NEW MEDICAL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For subcutaneous and intramuscular use. The function of the NMT Safety Syringe is to provide a safe and reliable method of injecting medication into a patient that also protects the user from potential needlesticks. The NMT Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
    Device Description
    The NMT Safety Syringe is a standard piston syringe with integral needle. The syringe incorporates automatic retraction technology that enables contaminated needles to be withdrawn, safely inside the body of the syringe when the syringe plunger is fully depressed. The NMT Safety Syringe is available as a 3cc syringe with 20 to 25g needles.
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