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

    STERILOX LIQUID CHEMICAL STERILANT SYSTEM

    K Number: K063159 · Decision Apr 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    167

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    Basic Information

    Device Name
    STERILOX LIQUID CHEMICAL STERILANT SYSTEM
    K Number
    K063159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puricore, Inc.
    Date Received
    October 17, 2006
    Decision Date
    April 2, 2007
    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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    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

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    Other Clearances by Puricore, Inc.

    K Number Device Name
    K141863 PURICORE WOUND HYDROGEL SPRAY DRESSING
    K131848 VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
    K123072 VASHE WOUND THERAPY SOLUTION
    K123071 VASHE SKIN AND WOUND HYDROGEL
    K100918 VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
    K093697 VASHE WOUND THERAPY SOLUTION
    K093155 VASHE WOUND CLEANSING SYSTEM
    K092232 MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
    K061689 AQUATINE EC ENDODONTIC CLEANSER