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510(k) Data Aggregation
K Number
K982188Device Name
STERI-PAK BOWIE DICK TEST PACKManufacturer
Date Cleared
1998-11-20
(151 days)
Product Code
Regulation Number
880.2800Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
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Device Name :
STERI-PAK BOWIE DICK TEST PACK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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