K Number
K002586Device Name
MEDPOR PTERIONAL SURGICAL IMPLANTManufacturer
Date Cleared
2000-11-17
(88 days)
Product Code
Regulation Number
878.3550Type
TraditionalPanel
SUReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.