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

    ACTION MEDTEK FACE SHIELD

    K Number: K926438 · Decision Aug 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    238

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    Basic Information

    Device Name
    ACTION MEDTEK FACE SHIELD
    K Number
    K926438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Action Eyewear Corp.
    Date Received
    December 23, 1992
    Decision Date
    August 18, 1993
    Product Code
    LYU
    Advisory Committee
    General, Plastic Surgery
    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
    LYU Accessory, Surgical Apparel

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    Other Clearances by Action Eyewear Corp.

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