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510(k) Data Aggregation
K Number
K980647Device Name
EYE IRRIGATOR MODEL #2020
Manufacturer
EYE-DEAL OCULAR SAFETY PRODUCTS, INC.
Date Cleared
1998-05-15
(87 days)
Product Code
KYG
Regulation Number
886.4360Why 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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