BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

    K Number: K131745 · Decision Sep 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    4
    Review Days
    96

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    Basic Information

    Device Name
    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
    K Number
    K131745
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helix Medical, LLC
    Date Received
    June 13, 2013
    Decision Date
    September 17, 2013
    Product Code
    LFB
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFB Button, Nasal Septal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LFB), ordered by most recent decision date.

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    MICROMEDICS NASAL SEPTAL BUTTON

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    NASAL SEPTAL BUTTON

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    FDA Unclassified ·Unknown

    HOOD NASAL SEPTAL BUTTON

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    FDA Unclassified ·Unknown

    INVOTEC SEPTAL BUTTON

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMEGA NASAL SEPTAL BUTTON

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    FDA Unclassified ·Unknown
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    K082206 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES