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510(k) Data Aggregation

    K Number
    K974482
    Device Name
    SILIMED GLUTEAL IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-02-24

    (90 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SILIMED GLUTEAL IMPLANT

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

    The Silicone Carving Block is designed to be used in acsthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.

    Device Description

    Silicone Carving Blocks

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily grants market clearance and does not contain the detailed study information you're asking for regarding acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information because the provided document (K974482) is a regulatory approval letter and not a study report. It does not contain the specifics about acceptance criteria and the study that proves the device meets those criteria.

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