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

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    K Number: K060618 · Decision Apr 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    CIDEX ACTIVATED DIALDEHYDE SOLUTION
    K Number
    K060618
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Co.
    Date Received
    March 8, 2006
    Decision Date
    April 12, 2006
    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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