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K Number
K981833
Device Name
SILIMED NASAL L SHAPED IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-06-26

(31 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

The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.

Device Description

Silimed Nasal "L" Shaped Implant

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to SILIMED, LLC regarding a Nasal "L" Shaped Implant. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is primarily focused on:

  • Confirming that the device is substantially equivalent to legally marketed predicate devices.
  • Informing SILIMED, LLC of their ability to market the device.
  • Outlining the general controls and regulations they must adhere to.
  • Stating the intended use of the device: "augmentation and reconstruction of the nasal contour."

Therefore, I cannot provide the requested information based on the input text.

§ 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.