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510(k) Data Aggregation
K Number
K011369Manufacturer
Date Cleared
2001-05-29
(25 days)
Product Code
Regulation Number
880.5860Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
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Device Name :
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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