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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    JOHN BRANCH

    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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