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510(k) Data Aggregation
K Number
K011183Device Name
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICEManufacturer
Date Cleared
2001-06-15
(58 days)
Product Code
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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