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510(k) Data Aggregation

    K Number
    K140352
    Device Name
    VERAPLUG
    Manufacturer
    KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
    Date Cleared
    2014-11-13

    (274 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
    Device Description
    The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter. The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
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