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

    OPA 30 SOLUTION

    K Number: K140703 · Decision Aug 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    152

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    Basic Information

    Device Name
    OPA 30 SOLUTION
    K Number
    K140703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciden Technologies, LLC
    Date Received
    March 20, 2014
    Decision Date
    August 19, 2014
    Product Code
    MED
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MED Sterilant, Medical Devices

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    Other Clearances by Ciden Technologies, LLC

    K Number Device Name
    K070627 OPACIDEN SOLUTION