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510(k) Data Aggregation

    K Number
    K040914
    Device Name
    POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
    Manufacturer
    EXERO PRODUCTS, INC.
    Date Cleared
    2004-05-27

    (49 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXERO PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PolyVial / PolyPak Contact Lens Case storuge system by Exero Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lenses during chemical disinfection
    Device Description
    The Poly Vial / PolyPak by Exero Products consists of a polypropylene body, polypropylene cap, with an integrated Thermoplastic Elastomer (TPE) seal in the cap that provides a hermetically sealed container for leak proof storage of hard, RGP (Rigid Gas Permeable) fluro silicone acrylate and silicone acrylate and Soft (hydrophilic) contact lonses during chemical disinfection The storage system consists of two removable side-by-side Poly Vials that rest on a PolyPak that clearly identifies the left from the right. The PolyVials are closed by simply pressing the cap down onto the base that engages the Thermoplastic Elastomer integrated in the cap to the flange portion of the polypropylene base.
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