BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LARYNGEAL

    K Number: K853726 · Decision Mar 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    19
    Review Days
    187

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    Basic Information

    Device Name
    LARYNGEAL
    K Number
    K853726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Hood Laboratories
    Date Received
    September 6, 1985
    Decision Date
    March 12, 1986
    Product Code
    FWN
    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
    FWN Prosthesis, Larynx (Stents And Keels)

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