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510(k) Data Aggregation

    K Number
    K982599
    Device Name
    THE FREMSTAD RING
    Manufacturer
    OPHTHALMIC SOLUTIONS, LLC.
    Date Cleared
    1999-02-16

    (204 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC SOLUTIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea.
    Device Description
    The Ophthalmic Solutions, LLC, The Fremstad Ring™ is used as a sponge. The device material consists of cellulosic and synthetic fibers. 14mm diameter, round, inner diameter 11mm, thickness 0.1 mm.
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