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510(k) Data Aggregation

    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
    General & Plastic Surgery
    Reference & Predicate Devices
    K973573,K973574,K973575
    Why did this record match?
    Reference 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.

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