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

    PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT

    K Number: K760435 · Decision Sep 27, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    71
    Applicant Total
    48
    Review Days
    42

    Basic Information

    Device Name
    PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
    K Number
    K760435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    RICHARD'S MEDICAL EQUIP., INC.
    Date Received
    August 16, 1976
    Decision Date
    September 27, 1976
    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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    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
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