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

    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES

    K Number: K001406 · Decision Aug 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    9
    Review Days
    97

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    Basic Information

    Device Name
    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
    K Number
    K001406
    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
    Mednet Locator, Inc.
    Date Received
    May 3, 2000
    Decision Date
    August 8, 2000
    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 Mednet Locator, Inc.

    K Number Device Name
    K001404 GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
    K974174 ULTRABUR
    K972734 PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
    K972735 TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
    K972737 CAUSSE PISTON
    K972126 MYRINGOTOMY TUBE
    K971943 MYRINGOTOMY TUBE
    K972400 MYRINGOTOMY TUBE - BOBBIN WITH TAB