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510(k) Data Aggregation

    K Number
    K183016
    Device Name
    SteriCap Mini Needle
    Manufacturer
    OcuJet, LLC
    Date Cleared
    2019-05-07

    (188 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OcuJet, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SteriCap™ Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs.
    Device Description
    The SteriCap™ Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in sizes ranging from 23G - 33G. The distal end of the needle has a spring-loaded needle cap, which protects the needle prior to use.
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    K Number
    K151571
    Device Name
    Mini Needle
    Manufacturer
    OCUJET, LLC
    Date Cleared
    2015-10-14

    (126 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCUJET, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.
    Device Description
    The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes. The distal end of the needle cap, which protects the needle prior to use.
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