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

    SEPTAL BUTTON

    K Number: K781529 · Decision Oct 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    82
    Review Days
    42

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    Basic Information

    Device Name
    SEPTAL BUTTON
    K Number
    K781529
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Xomed, Inc.
    Date Received
    September 5, 1978
    Decision Date
    October 17, 1978
    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

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    BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

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    MICROMEDICS NASAL SEPTAL BUTTON

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    NASAL SEPTAL BUTTON

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    HOOD NASAL SEPTAL BUTTON

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    FDA Unclassified ·Unknown

    INVOTEC SEPTAL BUTTON

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    FDA Unclassified ·Unknown
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    K002897 TITANIUM MIDDLE EAR PROSTHESES
    K993653 MICRO-FRANCE TROCARS AND ACCESSORIES
    K001148 MEROGEL OTOLOGIC PACK
    K994262 FRONTAL SINUS TREPHINATION CANNULA
    K992855 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
    K993582 MODIFICATION TO LASER-SHIELD II
    K993655 MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
    Search all 82 clearances from Xomed, Inc. →