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510(k) Data Aggregation
K Number
K002652Manufacturer
Date Cleared
2001-01-26
(154 days)
Product Code
Regulation Number
888.3027Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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