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

    PHOTOTHERAPY EYE PROTECTION FOR INFANTS

    K Number: K821765 · Decision Aug 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    PHOTOTHERAPY EYE PROTECTION FOR INFANTS
    K Number
    K821765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Russell Terry Co.
    Date Received
    June 14, 1982
    Decision Date
    August 16, 1982
    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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