BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PLASTI-PORE SEPTAL BUTTON

    K Number: K781574 · Decision Sep 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    48
    Review Days
    9

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    Basic Information

    Device Name
    PLASTI-PORE SEPTAL BUTTON
    K Number
    K781574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    September 18, 1978
    Decision Date
    September 27, 1978
    Product Code
    FZE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZE Prosthesis, Nose, Internal

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