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

    MILLARD MOUTH GAG

    K Number: K780992 · Decision Aug 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    MILLARD MOUTH GAG
    K Number
    K780992
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Nestor Engineering Associates, Inc.
    Date Received
    June 14, 1978
    Decision Date
    August 17, 1978
    Product Code
    KBN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KBN Gag, Mouth

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