BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RING SUPPORTED TREPHINE FOR CORNEA TRANS

    K Number: K843048 · Decision Oct 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    11
    Applicant Total
    4
    Review Days
    63

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    Basic Information

    Device Name
    RING SUPPORTED TREPHINE FOR CORNEA TRANS
    K Number
    K843048
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Precision Instruments, Inc.
    Date Received
    August 3, 1984
    Decision Date
    October 5, 1984
    Product Code
    HRH
    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
    HRH Trephine, Manual, Ophthalmic

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