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

    MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE

    K Number: K883480 · Decision Aug 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    5
    Applicant Total
    30
    Review Days
    8

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    Basic Information

    Device Name
    MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
    K Number
    K883480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4335
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    August 16, 1988
    Decision Date
    August 24, 1988
    Product Code
    FCT
    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
    FCT Headlight, Fiberoptic Focusing

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