LogoFDA 510(k) Search
K Number
K962261
Device Name
IMPLANTECH WM NASAL-LABIAL IMPLANT
Manufacturer
IMPLANTECH ASSOCIATES, INC.
Date Cleared
1996-08-19

(68 days)

Product Code
LZK
Regulation Number
878.3550
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.3550 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.