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510(k) Data Aggregation

    K Number
    K980647
    Device Name
    EYE IRRIGATOR MODEL #2020
    Manufacturer
    EYE-DEAL OCULAR SAFETY PRODUCTS, INC.
    Date Cleared
    1998-05-15

    (87 days)

    Product Code
    KYG
    Regulation Number
    886.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    EYE-DEAL OCULAR SAFETY PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.
    Device Description
    The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.
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