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

    SILMED NASAL SEPTAL BUTTON

    K Number: K013696 · Decision Nov 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    SILMED NASAL SEPTAL BUTTON
    K Number
    K013696
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silmed, Inc.
    Date Received
    November 7, 2001
    Decision Date
    November 28, 2001
    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

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