BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

    K Number: K213013 · Decision Sep 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    364

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    Basic Information

    Device Name
    Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
    K Number
    K213013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jeil Tech Co., Ltd.
    Date Received
    September 20, 2021
    Decision Date
    September 19, 2022
    Product Code
    QNQ
    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
    QNQ Low Dead Space Piston Syringe

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