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510(k) Data Aggregation

    K Number
    K211570
    Device Name
    Zeolite Hemostatic Gauze
    Manufacturer
    Hangzhou Zeo-Innov Life Technology Co., Ltd.
    Date Cleared
    2022-02-10

    (265 days)

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

    Hangzhou Zeo-Innov Life Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
    Device Description
    The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
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