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K Number
K090803
Device Name
HANSON MEDICAL FACIAL IMPLANTS
Manufacturer
HANSON MEDICAL, INC.
Date Cleared
2010-06-30

(463 days)

Product Code
FZE,ESR,FWP,LZK
Regulation Number
878.3680
Type
Traditional
Panel
SU
Reference & Predicate Devices
K973573,K973574,K973575
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour

Silicone Malar Implant – For the augmentation or reconstruction of the malar contour

Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the Hanson Medical Facial Implants. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily serves as an FDA clearance letter for a medical device, which is different from a study report detailing performance metrics.

§ 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.