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

    SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE

    K Number: K862943 · Decision Aug 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    30
    Review Days
    16

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    Basic Information

    Device Name
    SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
    K Number
    K862943
    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 5, 1986
    Decision Date
    August 21, 1986
    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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    K912739 SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
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