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

    MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS

    K Number: K955615 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    4
    Review Days
    11

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    Basic Information

    Device Name
    MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
    K Number
    K955615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Misten Medical Corp.
    Date Received
    December 11, 1995
    Decision Date
    December 22, 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 Misten Medical Corp.

    K Number Device Name
    K962163 MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
    K955616 MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
    K955613 MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS