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510(k) Data Aggregation
K Number
K961235Device Name
SIRIUS 180, 180L, 230, 230LManufacturer
Date Cleared
1997-01-08
(285 days)
Product Code
Regulation Number
872.4200Type
TraditionalPanel
Dental Devices (DE)Reference & Predicate Devices
N/A
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Device Name :
SIRIUS 180, 180L, 230, 230L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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