LogoFDA 510(k) Search
K Number
K962824
Device Name
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
Manufacturer
IMPLANTECH ASSOCIATES, INC.
Date Cleared
1996-10-03

(76 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.