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

    MODIFIED REUSABLE SITE FIBER OPTIC CABLE

    K Number: K883605 · Decision Oct 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    30
    Review Days
    63

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    Basic Information

    Device Name
    MODIFIED REUSABLE SITE FIBER OPTIC CABLE
    K Number
    K883605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    August 23, 1988
    Decision Date
    October 25, 1988
    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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