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

    ROBERT B. SCOTT PLASTIC ARTIFICAL

    K Number: K952538 · Decision Jun 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    ROBERT B. SCOTT PLASTIC ARTIFICAL
    K Number
    K952538
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.3200
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Robert B. Scott Ocularists of Florida, Inc.
    Date Received
    May 31, 1995
    Decision Date
    June 26, 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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    Other Clearances by Robert B. Scott Ocularists of Florida, Inc.

    K Number Device Name
    K772168 MOLDEYE