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

    LACRICATH LACRIMAL DUCT CATHETER

    K Number: K113867 · Decision Oct 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    39
    Review Days
    294

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    Basic Information

    Device Name
    LACRICATH LACRIMAL DUCT CATHETER
    K Number
    K113867
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Medical, Inc.
    Date Received
    December 30, 2011
    Decision Date
    October 19, 2012
    Product Code
    OKS
    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
    OKS Lacrimal Stents And Intubation Sets

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