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510(k) Data Aggregation

    K Number
    K140488
    Device Name
    CONTACT LENS CASE
    Manufacturer
    MACA PLASTICS, INC.
    Date Cleared
    2014-09-10

    (195 days)

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

    MACA PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. Do not use heat disinfection.
    Device Description
    Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.
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