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

    ARCTIC PREMIER SERIES

    K Number: K944700 · Decision Dec 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    769
    Registration Numbers
    769
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    ARCTIC PREMIER SERIES
    K Number
    K944700
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SUNGOLD EYEWEAR, INC.
    Date Received
    September 23, 1994
    Decision Date
    December 22, 1994
    Product Code
    HOY
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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