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510(k) Data Aggregation

    K Number
    K955900
    Device Name
    NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
    Manufacturer
    NOVAVISION, INC.
    Date Cleared
    1996-03-25

    (87 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    NOVALENS/NovaWet spherical and PERCEPTION and VANGUARD multifocal and/or bifocal (rosilfocon A) Rigid Gas Permeable Contact Lens (Clear and Blue Tinted) for Daily Wear (shipped in NovaSoak.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for contact lenses. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. Therefore, I cannot extract the requested information.

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