BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DEKA TAC DEVICE

    K Number: K093915 · Decision Aug 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    609

    Basic Information

    Device Name
    DEKA TAC DEVICE
    K Number
    K093915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research & Development Corp.
    Date Received
    December 22, 2009
    Decision Date
    August 23, 2011
    Product Code
    FIG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FIG Clamp, Tubing, Blood, Automatic

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