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

    SHEA TORP, OTOLOGY IMPLANT

    K Number: K760433 · Decision Oct 5, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    48
    Review Days
    50

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    Basic Information

    Device Name
    SHEA TORP, OTOLOGY IMPLANT
    K Number
    K760433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    August 16, 1976
    Decision Date
    October 5, 1976
    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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