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510(k) Data Aggregation

    K Number
    K131745
    Device Name
    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
    Manufacturer
    HELIX MEDICAL, LLC
    Date Cleared
    2013-09-17

    (96 days)

    Product Code
    LFB
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
    Device Description
    The Blom-Singer® Septal Perforation Prosthesis is a bi-flanged elastomeric device, each prosthesis are comprised of two (2) pieces which are attached to one another using a set of 2 enclosed magnets at the center of the flanges. The center post is either an oval or circular silicone stem that will fill most of the nasal septal perforation. The overlapping thin section or flange will extend beyond perforation to help with the closure of the perforation and the retention of the device. The flanges will be offered is various sizes and shapes to accommodate the individual's septal shape. In addition, the clinician may trim the flanges to fit. The device is intended to be used up to 29 days.
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    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?
    Product Code :

    LFB

    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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    K Number
    K982667
    Device Name
    MICROMEDICS NASAL SEPTAL BUTTON
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    1998-11-24

    (116 days)

    Product Code
    LFB
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-surgical closure of nasal septum perforation
    Device Description
    Not Found
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    K Number
    K972060
    Device Name
    NASAL SEPTAL BUTTON
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-07-03

    (31 days)

    Product Code
    LFB
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for non-surgical closure of nasal perforations.
    Device Description
    The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.
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