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510(k) Data Aggregation
K Number
K003397Device Name
COLLES C SERIES FRAME STERILE PACKManufacturer
Date Cleared
2001-01-29
(89 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
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Device Name :
COLLES C SERIES FRAME STERILE PACK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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