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510(k) Data Aggregation
K Number
K003489Manufacturer
Date Cleared
2001-02-02
(81 days)
Regulation Number
878.4580Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT;
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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