BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SPIVEY-ALLEN ORBITAL FLOOR IMPLANT

    K Number: K900930 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    12
    Review Days
    77

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    Basic Information

    Device Name
    SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
    K Number
    K900930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3340
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Oculo Plastik, Inc.
    Date Received
    February 27, 1990
    Decision Date
    May 15, 1990
    Product Code
    HQX
    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
    HQX Implant, Orbital, Extra-Ocular

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    Other Clearances by Oculo Plastik, Inc.

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