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510(k) Data Aggregation
K Number
K003977Device Name
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SETManufacturer
Date Cleared
2001-02-15
(55 days)
Product Code
Regulation Number
880.5440Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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