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510(k) Data Aggregation

    K Number
    K212635
    Device Name
    Sofjec
    Manufacturer
    Hwajin Medical Co.,Ltd.
    Date Cleared
    2023-02-13

    (543 days)

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

    Hwajin Medical Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.
    Device Description
    The device has three model with the following: (1) Single use Needle (108 model codes including Sofjec-16-13) Single use Needle consist of Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization. (2) Single use Syringe with Needle (1734 model codes including HJ-1-16G-13) Single use Syringe with Needle consist of Syringe, Cap, Needle and Hub and Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization and the syringes are two type of Luer Slip and Luer Lock. These device are injecting the medicine with syringes. This device is finished biocompatibility test and performance test for safety. (3) Membrane Filter Syringe (16 model codes including HJM-18-1) This devices are consists of membrane filter needle and syringe. Membrane filter needle is attached 0.5nm filtration membrane (Acrylic copolymer material). Syringe is two type. (Luer slip type and Luer lock type) This device is Filtering with syringes and injection device is finished biocompatibility test and performance test for safety.
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