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510(k) Data Aggregation

    K Number
    K060924
    Device Name
    JSZ MULTIACTION GP CONTACT LENS SOLUTION
    Manufacturer
    SZABOCSIK AND ASSOCIATES
    Date Cleared
    2006-06-28

    (85 days)

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

    SZABOCSIK AND ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JSZ MultiAction GP Contact Lens Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfection, storage and conditioning of rigid gas permeable contact lenses, including fluorosilicone acrylate and silicone acrylate lenses, as recommended by your eye care practitioner. JSZ Wetting/Rewetting Eyedrop is indicated to rewet soft (hydrophilic) and to cushion and wet rigid gas permeable contact lenses, including fluoro-silicone acrylate and silicone acrylate lenses, before application and during lens wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.
    Device Description
    Both products are sterile, isotonic solutions that contain poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polydum ide 0.0001%. Contain no chlorhexidine, no thimerosal, nor any other mercury containo products. The products are packaged in sizes appropriate to their intended uses: JSZ MultiAction GP Contact Lens Solution in 2oz (60ml) and 4oz (120ml) bottles, JSZ Wetting/Rewetting Eyedrop in 0.5oz (15ml) and 1oz (30ml) bottles.
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    K Number
    K052074
    Device Name
    JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
    Manufacturer
    SZABOCSIK AND ASSOCIATES
    Date Cleared
    2005-09-01

    (31 days)

    Product Code
    MRC
    Regulation Number
    886.5918
    Why did this record match?
    Applicant Name (Manufacturer) :

    SZABOCSIK AND ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JSZ-Stat-Tree Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Stat-Or Cleaning, Disinfecting, Storage Solution is indicated for use in the cleaning, chemical disinfection and storage of fluoro/silicone acrylate and silicone acrylate (RGP) contact lenses. JSZ-Wet-Tree Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye. JSZ-Wet-Or Wetting. Lubricating, Rewetting Drops are indicated for use to wet fluoro/silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses prior to lens insertion and to rewet and lubricate the lens while on the eye.
    Device Description
    Cleaning, Disinfecting and Storing Solutions; and Wetting, Lubricating and Rewetting Solutions for Rigid Gas Permeable Contact Lenses.
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    K Number
    K050517
    Device Name
    JSZ-MULTIPURPOSE SOLUTION
    Manufacturer
    SZABOCSIK AND ASSOCIATES
    Date Cleared
    2005-04-13

    (43 days)

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

    SZABOCSIK AND ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JSZ Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
    Device Description
    The JSZ-Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. This product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
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