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510(k) Data Aggregation

    K Number
    K974288
    Device Name
    ZEROWET SPLASHIELD
    Manufacturer
    ZEROWET, INC.
    Date Cleared
    1998-01-29

    (76 days)

    Product Code
    KYZ
    Regulation Number
    880.6960
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZEROWET, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerower Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation.
    Device Description
    The device of the current submission is an unsterilized styrene bell-shaped unit, with a 19g nozzle integrated in the stem which attaches to the end of a syringe. The intended use is as attached to the end of an irrigation syringe, during wound irrigation, to protect the user from (a) needlesticks (by eliminating the use of a needle), and (b) bloody splash during this procedure.
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