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

    STAPES PROSTHESES

    K Number: K991394 · Decision May 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    71
    Applicant Total
    14
    Review Days
    27

    Basic Information

    Device Name
    STAPES PROSTHESES
    K Number
    K991394
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grace Medical, Inc.
    Date Received
    April 21, 1999
    Decision Date
    May 18, 1999
    Product Code
    ETB
    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
    ETB Prosthesis, Partial Ossicular Replacement

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