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510(k) Data Aggregation
K Number
K113583Device Name
CURAD ANTIBACTERIAL BANDAGEManufacturer
Date Cleared
2012-04-12
(129 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
CURAD ANTIBACTERIAL BANDAGE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Antibacterial bandages are to be applied topically to the skin to help prevent infection in minor cuts, scrapes and burns.
Device Description
Not Found
AI/ML Overview
This document is an FDA 510(k) clearance letter for the Curad Antibacterial Bandage. It does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from this document.
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