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510(k) Data Aggregation
K Number
K223495Device Name
Zeolite Hemostatic Cotton
Manufacturer
Date Cleared
2023-05-02
(162 days)
Product Code
Regulation Number
N/AWhy 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
K211570Device Name
Zeolite Hemostatic Gauze
Manufacturer
Date Cleared
2022-02-10
(265 days)
Regulation Number
N/AWhy 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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