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510(k) Data Aggregation

    K Number
    K173743
    Date Cleared
    2019-01-28

    (417 days)

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

    Sang-A Frontec Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when into the human body to remove foreign substances from the drug solutions.

    Device Description

    The Greenmedi safety filter syringe consists of a plunger that fits tightly within a barrel and a needle. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid through a needle. After use, the health care professional fully depresses the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a sharps container.

    AI/ML Overview

    This is a 510(k) summary for a medical device called the Greenmedi Safety Filter Syringe. It does not contain information about an AI/ML powered device, therefore, the requested information cannot be extracted.

    No AI/ML related information is present in the provided document.

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