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

    SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION

    K Number: K063069 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    280

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    Basic Information

    Device Name
    SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
    K Number
    K063069
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Molecular Therapuetics, LLC
    Date Received
    October 6, 2006
    Decision Date
    July 13, 2007
    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 Medical Molecular Therapuetics, LLC

    K Number Device Name
    K063063 SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION