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510(k) Data Aggregation

    K Number
    K130753
    Device Name
    STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
    Manufacturer
    WATCHDOG GROUP, LC
    Date Cleared
    2013-06-13

    (86 days)

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

    WATCHDOG GROUP, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.
    Device Description
    The contact lens cases are designed for storage of contact lenses. The Color Case Contact Lens Case has 2 adjoining wells that have screw top caps. The Flip N Slide Contact Lens Case model has 2 adjoining wells with integral hinged, self-sealing caps in which contact lenses are immersed. The devices are not sterile and are not for heat disinfection. They are made of polypropylene plastic. The volume capacity is 5.91 ml on each well of both lens cases.
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