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

    ACTION MEDTEK/DENTEK EYEGLASSES

    K Number: K925564 · Decision Oct 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    338

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    Basic Information

    Device Name
    ACTION MEDTEK/DENTEK EYEGLASSES
    K Number
    K925564
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Action Eyewear Corp.
    Date Received
    November 3, 1992
    Decision Date
    October 7, 1993
    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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    Other Clearances by Action Eyewear Corp.

    K Number Device Name
    K926438 ACTION MEDTEK FACE SHIELD