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510(k) Data Aggregation

    K Number
    K151575
    Device Name
    Dynarex Eye Cups
    Manufacturer
    DYNAREX CORPORATION
    Date Cleared
    2015-09-01

    (82 days)

    Product Code
    LXQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.
    Device Description
    The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.
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    K Number
    K140409
    Device Name
    FLENTS PLASTIC EYE WASH CUP
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Date Cleared
    2014-07-09

    (141 days)

    Product Code
    LXQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
    Device Description
    The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The Flents Plastic Eye Wash Cup is non-sterile and is reusable.
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    K Number
    K051414
    Device Name
    EYE CUP, STERILE 1 AND NON STERILE
    Manufacturer
    TOLLOT PTY.LTD.(AAXIS PACIFIC)
    Date Cleared
    2005-06-16

    (16 days)

    Product Code
    LXQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Cup Sterile I 's and the Eye Cup Non Sterile are each a cup that holds liquids, such as eye wash solution, used to flush out the eye.
    Device Description
    a) Eye Cup Sterile 1's b) Eye Cup Non Sterile
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    K Number
    K971134
    Device Name
    VISTA EYESHOWER
    Manufacturer
    JOHN BRANCH
    Date Cleared
    1997-11-04

    (221 days)

    Product Code
    LXQ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LXQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water. For Over-The-Counter use.
    Device Description
    The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye.
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