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510(k) Data Aggregation

    K Number
    K200641
    Device Name
    HaloGUARD Protective Disc with CHG
    Manufacturer
    ATTWILL Medical Solutions
    Date Cleared
    2020-09-03

    (176 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATTWILL Medical Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.
    Device Description
    HaloGUARD™ Protective Disc with CHG is a sterile, single use disposable disc infused with the antibacterial agent chlorhexidine gluconate (CHG).
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