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510(k) Data Aggregation
K Number
K011512Device Name
MMODIFICATION TO LAMINARIAManufacturer
Date Cleared
2001-07-09
(54 days)
Product Code
Regulation Number
884.4260Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
MMODIFICATION TO LAMINARIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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