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

    BIO-EYE II ORBITAL IMPLANT

    K Number: K003338 · Decision Feb 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    38
    Applicant Total
    5
    Review Days
    105

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    Basic Information

    Device Name
    BIO-EYE II ORBITAL IMPLANT
    K Number
    K003338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integrated Orbital Implants, Inc.
    Date Received
    October 25, 2000
    Decision Date
    February 7, 2001
    Product Code
    HPZ
    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
    HPZ Implant, Eye Sphere

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    Other Clearances by Integrated Orbital Implants, Inc.

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