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

    STERILOX LIQUID CHEMICAL STERILANT SYSTEM

    K Number: K013280 · Decision Sep 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    351

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    Basic Information

    Device Name
    STERILOX LIQUID CHEMICAL STERILANT SYSTEM
    K Number
    K013280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilox Technologies, Inc.
    Date Received
    October 2, 2001
    Decision Date
    September 18, 2002
    Product Code
    MED
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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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    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

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    Other Clearances by Sterilox Technologies, Inc.

    K Number Device Name
    K060901 VASHE WOUND CLEANSING SYSTEM