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510(k) Data Aggregation

    K Number
    K203264
    Device Name
    MicroDose Injector
    Manufacturer
    MedOne Surgical, Inc.
    Date Cleared
    2021-04-26

    (172 days)

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

    MedOne Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.
    Device Description
    The MicroDose Injector is designed for low volume ophthalmic injection into the subretinal space. It consists of one (1)1mL syringe and one (1) connector, which is joined to VFC tubing that is attached to a pneumatic air source, enabling a surgeon control for administering subretinal injections. The device is supplied sterile and intended for single-use only and cannot be reused or resterilized.
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