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510(k) Data Aggregation
K Number
K132730Device Name
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACEManufacturer
Date Cleared
2014-05-30
(269 days)
Product Code
Regulation Number
870.2120Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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