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510(k) Data Aggregation
K Number
K200821Device Name
anti-bacterial bandage
Manufacturer
Planet (Suzhou) Medical Products Co., Ltd
Date Cleared
2020-10-19
(203 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Planet (Suzhou) Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
Device Description
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes. Anti-bacterial bandage is made of Fabric tape/polyethylene tape, and absorbent pad. Absorbent pad contains 0.1%/0.8% benzalkonium chloride. The Anti-bacterial bandage is EO sterilized, and is for single use only. Product shelf- life time: Three years
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