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510(k) Data Aggregation
K Number
K011122Device Name
BALLPEN SPINAL NEEDLE W/WO INTRODUCERManufacturer
Date Cleared
2001-11-16
(218 days)
Product Code
Regulation Number
868.5150Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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