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510(k) Data Aggregation

    K Number
    K983755
    Device Name
    NASAL DORSAL SERIES
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1998-11-20

    (29 days)

    Product Code
    FZE
    Regulation Number
    878.3680
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NASAL DORSAL SERIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Surgical Technology Laboratories, Inc. for their "Nasal Dorsal Series" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about the clinical studies requested in your prompt.

    Therefore, I cannot provide the requested table and study information based on the given document.

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