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

    FLEX-CUP PERCUSSOR

    K Number: K892862 · Decision May 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    57
    Applicant Total
    29
    Review Days
    37

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    Basic Information

    Device Name
    FLEX-CUP PERCUSSOR
    K Number
    K892862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Life Design Systems, Inc.
    Date Received
    April 18, 1989
    Decision Date
    May 25, 1989
    Product Code
    BYI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYI Percussor, Powered-Electric

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