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

    ELLIPTI-PUNCH

    K Number: K854159 · Decision Nov 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    47
    Review Days
    35

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    Basic Information

    Device Name
    ELLIPTI-PUNCH
    K Number
    K854159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Alcon Laboratories
    Date Received
    October 11, 1985
    Decision Date
    November 15, 1985
    Product Code
    FZI
    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
    FZI Apparatus, Air Handling, Enclosure

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