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

    KIMGUARD ONE-STEP Sterilization Wrap

    K Number: K143053 · Decision Apr 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    5
    Review Days
    162

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    Basic Information

    Device Name
    KIMGUARD ONE-STEP Sterilization Wrap
    K Number
    K143053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark Health Care
    Date Received
    October 23, 2014
    Decision Date
    April 3, 2015
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    Other Clearances by Kimberly-Clark Health Care

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    K113806 KIMGUARD ONE STEP STERILIZATION WRAP