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510(k) Data Aggregation

    K Number
    K990479
    Device Name
    HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR
    Manufacturer
    HYGENITEK, INC.
    Date Cleared
    1999-05-13

    (86 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYGENITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To isolate water delivery lines in the dental operatory unit and reduce the contamination due to To isolate watch delivery mics in the dental operation, to dental handpieces and other dental instruments.
    Device Description
    Accessory to dental unit, dental line-cleaner, Water-Delivery Device
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