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510(k) Data Aggregation
K Number
K001287Manufacturer
Date Cleared
2000-06-09
(46 days)
Product Code
Regulation Number
880.5025Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
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Device Name :
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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