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

    TREBAY TOTAL RECTANGULAR HEAD

    K Number: K954518 · Decision Oct 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    14
    Review Days
    29

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    Basic Information

    Device Name
    TREBAY TOTAL RECTANGULAR HEAD
    K Number
    K954518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trebay Medical Corp.
    Date Received
    September 28, 1995
    Decision Date
    October 27, 1995
    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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    Other Clearances by Trebay Medical Corp.

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    K954517 TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
    K954715 MICRO-PLANER HANDPIECE
    K952226 C-FLEX SEPTAL SPLINTS
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