K Number
K010583Device Name
AMBU GEL, HYDROGEL BURN DRESSINGManufacturer
Date Cleared
2001-05-25
(87 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
SUReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A