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510(k) Data Aggregation
K Number
K071160Device Name
REFLECTION, TANDEM UNIPOLARManufacturer
Date Cleared
2007-10-05
(162 days)
Regulation Number
888.3358Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
REFLECTION, TANDEM UNIPOLAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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