BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR

    K Number: K911072 · Decision May 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
    K Number
    K911072
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    A & F Products
    Date Received
    March 11, 1991
    Decision Date
    May 15, 1991
    Product Code
    EHZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EHZ Evacuator, Oral Cavity

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