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K Number
K981850
Device Name
SILIMED CHIN IMPLANTS
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09

(44 days)

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

The Silimed Chin Implants are intended for use in aesthetic, corrective or reconstructive surgery of the chin.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for Silimed Chin Implants, dated July 9, 1998. It primarily addresses the regulatory approval process and doesn't contain information about acceptance criteria or performance studies for the device. Therefore, I cannot provide the requested information.

§ 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.