BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇻🇳 Vietnam

    Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

    K Number: K232950 · Decision Jun 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
    K Number
    K232950
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perfect Medical Industry (Vn) Co., Ltd.
    Date Received
    September 20, 2023
    Decision Date
    June 12, 2024
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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