K Number
K953690Device Name
CLS STEM (MODIFICATION)Manufacturer
Date Cleared
1996-06-07
(312 days)
Product Code
Regulation Number
888.3353Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A