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510(k) Data Aggregation
K Number
K964369Device Name
TRACH CARE SET WITH MICROBANManufacturer
Date Cleared
1997-02-11
(102 days)
Product Code
Regulation Number
868.6810Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
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Device Name :
TRACH CARE SET WITH MICROBAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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