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

    DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER

    K Number: K962290 · Decision Jul 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    4
    Applicant Total
    4
    Review Days
    19

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    Basic Information

    Device Name
    DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
    K Number
    K962290
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5270
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Debusk Technology Corp.
    Date Received
    June 14, 1996
    Decision Date
    July 3, 1996
    Product Code
    FOK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOK Pad, Neonatal Eye

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