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

    BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

    K Number: K843461 · Decision Jan 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    126

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    Basic Information

    Device Name
    BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
    K Number
    K843461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    American Biomaterials Corp.
    Date Received
    September 5, 1984
    Decision Date
    January 9, 1985
    Product Code
    ETA
    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
    ETA Replacement, Ossicular Prosthesis, Total

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