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

    ORAL AIRWAYS

    K Number: K810651 · Decision Mar 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    ORAL AIRWAYS
    K Number
    K810651
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    First Industries, Inc.
    Date Received
    March 10, 1981
    Decision Date
    March 31, 1981
    Product Code
    CAE
    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
    CAE Airway, Oropharyngeal, Anesthesiology

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