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

    OPHTACATH KIT

    K Number: K123831 · Decision Jul 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    229

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    Basic Information

    Device Name
    OPHTACATH KIT
    K Number
    K123831
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    France Chirurgae Instrumentation
    Date Received
    December 12, 2012
    Decision Date
    July 29, 2013
    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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