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510(k) Data Aggregation

    K Number
    K962989
    Device Name
    AMOILS EPITHELIAL SCRUBBER
    Manufacturer
    S. PERCY AMOILS
    Date Cleared
    1997-01-09

    (161 days)

    Product Code
    HOG
    Regulation Number
    886.4070
    Why did this record match?
    Product Code :

    HOG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.
    Device Description
    The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.
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    K Number
    K960261
    Device Name
    PALLIKARIS BRUSH
    Manufacturer
    ALCON LABORATORIES, INC.
    Date Cleared
    1996-03-11

    (53 days)

    Product Code
    HOG
    Regulation Number
    886.4070
    Why did this record match?
    Product Code :

    HOG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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