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

    STEINWAY MICRO-KERATO-TREPHINE

    K Number: K843646 · Decision Jan 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    STEINWAY MICRO-KERATO-TREPHINE
    K Number
    K843646
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Steinway Instrument Co., Inc.
    Date Received
    September 17, 1984
    Decision Date
    January 3, 1985
    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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