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

    E-Z-GUARD MOUTHPIECE

    K Number: K853402 · Decision Oct 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    162
    Registration Numbers
    162
    Same Product Code
    24
    Applicant Total
    56
    Review Days
    72

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    Basic Information

    Device Name
    E-Z-GUARD MOUTHPIECE
    K Number
    K853402
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    August 12, 1985
    Decision Date
    October 23, 1985
    Product Code
    BYP
    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
    BYP Mouthpiece, Breathing

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