BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CUSTOM ARTIFICIAL HUMAN EYES

    K Number: K945270 · Decision May 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    214

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    Basic Information

    Device Name
    CUSTOM ARTIFICIAL HUMAN EYES
    K Number
    K945270
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.3200
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Daniel T Acosta
    Date Received
    October 28, 1994
    Decision Date
    May 30, 1995
    Product Code
    HQH
    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
    HQH Eye, Artificial, Non-Custom

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