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510(k) Data Aggregation

    K Number
    K013696
    Device Name
    SILMED NASAL SEPTAL BUTTON
    Manufacturer
    SILMED, INC.
    Date Cleared
    2001-11-28

    (21 days)

    Product Code
    LFB
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.
    Device Description
    Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large. The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular flanges come in varying diaments depending on the size of the button. The central post is elliptical in shape and can also be explained as an elongated circular section. The post dimensions vary with size and with the circular flange diameter based on the size of the nasal perforation and can be trimmed at the time of placement.
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