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510(k) Data Aggregation
K Number
K000778Manufacturer
Date Cleared
2000-05-03
(54 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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