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

    FISCH MODIFIED TOTAL OSSICULAR PROSTHES

    K Number: K823442 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    80
    Review Days
    17

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    Basic Information

    Device Name
    FISCH MODIFIED TOTAL OSSICULAR PROSTHES
    K Number
    K823442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Treace Medical, Inc.
    Date Received
    November 16, 1982
    Decision Date
    December 3, 1982
    Product Code
    LBM
    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
    LBM Porous Polyethylene Ossicular Replacement

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    K870765 CANNULATED INSTRUMENT CLEANERS
    K871706 OPTHA PREP
    K870759 CLEANING SOLUTION, CATALOG NO. 8203
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