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

    FLENTS PLASTIC EYE WASH CUP

    K Number: K140409 · Decision Jul 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    141

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    Basic Information

    Device Name
    FLENTS PLASTIC EYE WASH CUP
    K Number
    K140409
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apothecary Products, Inc.
    Date Received
    February 18, 2014
    Decision Date
    July 9, 2014
    Product Code
    LXQ
    Advisory Committee
    Unknown
    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
    LXQ Cup, Eye

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