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510(k) Data Aggregation
K Number
K011222Device Name
PORTABELL, MODEL 4200Manufacturer
Date Cleared
2001-06-25
(66 days)
Product Code
Regulation Number
872.6640Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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