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510(k) Data Aggregation
K Number
K101186Manufacturer
Date Cleared
2010-09-03
(128 days)
Product Code
Regulation Number
870.4230Type
TraditionalPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
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Device Name :
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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