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K Number
K071018
Device Name
MONARCH NASAL IMPLANT
Manufacturer
HANSON MEDICAL, INC.
Date Cleared
2007-05-25

(45 days)

Product Code
FZE
Regulation Number
878.3680
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.