BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

    K Number: K243149 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    81

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    Basic Information

    Device Name
    Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
    K Number
    K243149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Congruence Medical Solutions, LLC
    Date Received
    September 30, 2024
    Decision Date
    December 20, 2024
    Product Code
    QLY
    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
    QLY Ophthalmic Syringe

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