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

    STRAITH ORAL AIRWAY

    K Number: K831078 · Decision Jun 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    12
    Review Days
    81

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    Basic Information

    Device Name
    STRAITH ORAL AIRWAY
    K Number
    K831078
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Surgical Technology Laboratories, Inc.
    Date Received
    April 4, 1983
    Decision Date
    June 24, 1983
    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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