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

    SYN-O-SCOPE NASAL INHALER

    K Number: K760674 · Decision Mar 10, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    SYN-O-SCOPE NASAL INHALER
    K Number
    K760674
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Mcdonald and Assoc., Inc.
    Date Received
    September 16, 1976
    Decision Date
    March 10, 1977
    Product Code
    KCO
    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
    KCO Nasal Spray, Ent Delivery