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

    GLAUCOMA MECHANICAL TREPHINE

    K Number: K895813 · Decision Apr 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    148
    Applicant Total
    8
    Review Days
    210

    Basic Information

    Device Name
    GLAUCOMA MECHANICAL TREPHINE
    K Number
    K895813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    TREK MEDICAL PRODUCTS, INC.
    Date Received
    October 2, 1989
    Decision Date
    April 30, 1990
    Product Code
    HQE
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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