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

    EYE CUP, STERILE 1 AND NON STERILE

    K Number: K051414 · Decision Jun 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    EYE CUP, STERILE 1 AND NON STERILE
    K Number
    K051414
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tollot Pty.Ltd.(Aaxis Pacific)
    Date Received
    May 31, 2005
    Decision Date
    June 16, 2005
    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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