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

    WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)

    K Number: K897089 · Decision Apr 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1086
    Registration Numbers
    1086
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    WEE-PEEPERS (CUSHIONED CHILDREN'S SUNSHADES)
    K Number
    K897089
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Inno-Lite Co., Inc.
    Date Received
    December 20, 1989
    Decision Date
    April 23, 1990
    Product Code
    HQZ
    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
    HQZ Frame, Spectacle

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