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510(k) Data Aggregation

    K Number
    K223495
    Device Name
    Zeolite Hemostatic Cotton
    Date Cleared
    2023-05-02

    (162 days)

    Product Code
    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 AuthorizedThirdparty
    Intended Use
    Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: Zeolite Hemostatic Cotton is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
    Device Description
    The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
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    K Number
    K211570
    Device Name
    Zeolite Hemostatic Gauze
    Date Cleared
    2022-02-10

    (265 days)

    Product Code
    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 AuthorizedThirdparty
    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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