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510(k) Data Aggregation

    K Number
    K162869
    Device Name
    Contact Lens Case
    Manufacturer
    Ningbo Yinzhou Zonghai Artware Co., Ltd.
    Date Cleared
    2016-12-09

    (57 days)

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

    Ningbo Yinzhou Zonghai Artware Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
    Device Description
    The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses. The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.
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