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

    NIXALL TM WOUND AND SKIN CARE

    K Number: K113693 · Decision Dec 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    361

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    Basic Information

    Device Name
    NIXALL TM WOUND AND SKIN CARE
    K Number
    K113693
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seriously Clean, Ltd.
    Date Received
    December 16, 2011
    Decision Date
    December 11, 2012
    Product Code
    FRO
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRO Dressing, Wound, Drug

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    Other Clearances by Seriously Clean, Ltd.

    K Number Device Name
    K243457 Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel