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

    INVOTEC SEPTAL BUTTON

    K Number: K901366 · Decision Jun 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    16
    Review Days
    83

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    Basic Information

    Device Name
    INVOTEC SEPTAL BUTTON
    K Number
    K901366
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Invotec International, Inc.
    Date Received
    March 23, 1990
    Decision Date
    June 14, 1990
    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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