K Number
K003396Device Name
BURN JEL PLUSManufacturer
Date Cleared
2001-01-11
(71 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A